1 Job Beskrivelse Primære opgaver Uddannelse og professionel erfaring Personlige kompetencer Akademiker til product care og produktions support Production Support er én ud af i alt 6 afdelinger i produktionen. Afdelingen består pt. af 21 medarbejdere heraf er de fleste akademikere. Afdelingens ansvarsområder er at give support til produktionen, at overvåge om vores udstyr og produktionsprocesser lever op til gældende krav, at overføre nye produkter fra R&D til produktionen, samt at deltage i Product Care eller optimerings projekter. Processerne spænder bredt fra bl.a. oprensning af antistoffer, immunohistokemi til påfyldning, labeling og pakning.alt arbejde foregår i henhold til ISO9001 og ISO13485 og vi arbejder efter GMP regler (Bekendtgørelse af medical device og FDA krav 21CFR820). Tage ansvar for løbende at forbedre compliance for vores eksisterende produkter, herunder afvigelsesbehandling og håndtering af kundeklager At supportere vores produktionsafdelinger iht. gældende regler Optimere eksisterende processer og produkter ISO dokumentation: opdatering af dokumenter i vores kvalitetssystem Du vil få et ansvarsfuldt job med en stor berøringsflade i Dako, idet du vil arbejde tæt sammen med kollegaer i de forskellige produktionsteams, RA/QA, Customer Care, marketing samt R&D. Du er uddannet molekylær biolog, kemi ingeniør eller har en anden Sætter du en ære i at planlægge, gennemføre og afslutte relevant videregående uddannelse, gerne suppleret med en phd. Du opgaver til fastsatte deadlines har erfaring fra R&D, process development eller produktionssupport fra Er du i stand til at arbejde både selvstændigt og i team samt at en Life science virksomhed. Du er bekendt med de kvalitetsmæssige få motiveret andre til at bidrage til teamets leverancer standarder, som vi opererer under. Du er god til at koordinere Er du energisk og har et synligt drive projekter.du behersker engelsk i skrift og tale (koncernsproget er Er du positiv og har du et godt humør engelsk). Scientist, Upstream Development The position entails hands on development of consistent and robust upstream processes using Drosophila S2 insect cells in various types of bioreactors using batch, fed batch and perfusion modes. The process development will be captured in standard operating procedures (SOPs) and the scientist will form part of the team transferring the processes to a contract manufacturer for GMP production. Furthermore, routine protein production for client projects in scales ranging from 500ml to 15L will be performed on an ongoing basis. Ph.D. degree in a life science discipline Experience with bioreactor systems is critical to this position Experience with animal or insect cell culture would be a distinct advantage Experience from upstream development departments, e.g. biotech, Pharma, contract manufacturer or contract research organisation Solid knowledge or experience with GMP Team player Fluency in English Well organised, self starter Account Manager As an Account Manager you will be responsible Actively scout for new opportunities at existing and potential new accounts for sales, marketing strategies and customer Maintain accurate customer and prospect information utilizing approved support in Denmark, Finland, Norway and Sweden information and database tools and technologies Provide hands on training to customers and to actively support the set up of new products and technologies Provide high level information about techniques and products with the continuous aim of optimizing sales success Ensure the territory prospect pipeline is populated with a balance of short, mid and long term prospects sufficient for the continuous attainment of the short and long term targets B.Sc. or M.Sc. degree in Science (biology, biochemistry or molecular biology).you should have experience in a similar role. We are looking for a results oriented person with proactive mindset and strong sense of ownership. We expect you to have the ability to operate independently and as part of a team in a multicultural environment with an aptitude and desire to sell. We also expect you to have the ability to analyze and solve complex problems. To be successful in this position you need to be highly communicative Afdelingschef til Regulatory Affairs Stillingen som afdelingschef er en udfordrende og udviklende stilling, hvor du vil blive overordnet ansvarlig for den strategiske og operationelle udvikling af det regulatoriske område samt planlægning og gennemførelse af de fastlagte mål. Derudover skal du agere som en stærk motivator og personaleleder for medarbejderne i afdelingen. Registrering og vedligehold af produktporteføljen i en række lande Varetagelse af pharmacovigilance opgaver, PSUR etc. Regulatoriske aspekter ifm partnerskaber og kontrakter Liason med myndigheder i de forskellige lande Udvikling af afdelingens medarbejdere og processer Regulatoriske strategier for effektiv produktudvikling Du kommer til at indgå i et tæt samarbejde med øvrige chefer og får en bred kontaktflade i resten af organisationen. Vi forventer, at du har en relevant videregående uddannelse Du skal stå i spidsen for en afdeling med høj faglighed og Solid erfaring inden for global regulatory affairs stramme deadlines. Det er derfor vigtigt, at du udviser stor Dokumenteret erfaring med udvikling og godkendelse af humane gennemslagskraft og handlekraft. Du er en overbevisende leder, lægemidler og du er god til at motivere dine medarbejdere gennem en fælles Indgående kendskab til gældende registreringskrav for lægemidler indsats. Solid erfaring med personaleledelse Det vil være en fordel, hvis du har erfaring med biologiske lægemidler og kendskab til pharmacovigilance i EU. Derudover er kendskab til LEAN ledelse en fordel, men ikke et krav.
2 Akademiker til Pharmacovigilance og QA None Behandle bivirkninger, reklamationer og andre safety relaterede dokumenter Foretage litteratursøgninger i tidsskrifter for bivirkninger Fungere som QPPV stedfortræder Stå for kontakten med samarbejdspartnere (bl.a. distributører) og træning af disse samt ansvar for at vedligeholde kontrakter med samarbejdspartnere Kontakt til og kvalificering af leverandører Du har uddannelse som farmaceut eller lignende og gerne et par års erfaring fra lignende stilling i medicinalindustrien Du er god til engelsk i skrift og tale Du er god til at planlægge og afslutte dine opgaver, har øje for detaljen samt overblik Du arbejder selvstændigt, men er en del af et team Du er fleksibel, målrettet og ansvarsbevidst Du er udadvendt, har godt humør og er god til at kommunikere Akademiker til Quality Site Afdelingen er ansvarlig for at sikre kvaliteten af ALKs produkter produceret på sitet i Hørsholm og hos kontraktfremstillere. Herunder hører alle processer linket til frigivelse af råvarer, API, bulk, færdigvarer samt kvalificering, validering, interne audits/selvinspektioner, deltagelse i audits af leverandører og kontraktfremstillere, modtagelse af inspektioner fra myndigheder og kunder på sitet i Hørsholm samt generel GMP og GDP compliance. Batch review og frigivelse af produkter til det kommercielle marked, herunder kontakt til internationale samarbejdspartnere og kontraktfremstillere Validering af processer f.eks. indenfor API og/eller aseptisk produktion Håndtering af miljø relaterede opgaver (vand, HVAC, rutine monitorering etc.) Projektdeltagelse i bl.a. optimeringsprojekter og implementering af nye produkter Håndtering af afvigelser, CAPA er og ændringssager Udførelse af audits, herunder både interne og eksterne audits Kvalitetsforbedringer, systemer og processer Er farmaceut, ingeniør eller har tilsvarende uddannelse Det er fordel hvis du har erfaring indenfor følgende, men ikke et krav: Har erfaring indenfor kvalitet Har erfaring med at arbejde efter GMP Har erfaring med produktionssupport, validering af processer f.eks. indenfor API, aseptisk produktion og/eller færdigvare, samt håndtering af miljø relaterede opgaver Ser QA som en aktiv samarbejdspartner til resten af organisationen Er rutineret bruger af MS Office Har et godt kendskab til engelsk både skriftligt og mundtligt Trives med at have en bred kontaktflade og koordinerende rolle inklusiv opfølgning i og udenfor afdelingen Motiveres af mange forskellige opgaver, højt tempo og mange deadlines i projektarbejde såvel som rutineopgaver Arbejder selvstændigt og struktureret Akademiker til Scientific Support Teknisk support til vores kunder specielt indenfor ELISA, turbidimetri og nephelometri. Samarbejde med og teknisk support til produktionsafdelinger. Analytisk arbejde omkring kunders tekniske behov i forbindelse med forretningsudvikling. Du er ingeniør, biolog, humanbiolog, biokemiker eller tilsvarende gerne med en PhD grad. Erfaring med klinisk biokemi fra et hospitalslaboratorium og praktisk kendskab til proteinoprensinger, antistofoprensinger og ELISA vil være en stor fordel. Erfaring med proteinkemi, koblingskemi, immunologi, turbidimetri og nephelometri vil være relevant. Du behersker engelsk på forretningsniveau (koncernsprog). Du arbejder selvstændigt og systematisk og taber ikke overblikket i pressede situationer. Du befinder dig godt ved at arbejde i et team om fælles løsning af opgaver og besidder gode samarbejdsevner. Du er energisk og har stort drive. Du er forretnings, kunde og resultatorienteret. Akademiker til udvikling af IHC reagenser Afdelingens funktion er at udvikle reagenser til hele den immunhistokemiske procedure. Reagenserne udvikles til instrumentbrug med fokus på optimalt samspil mellem reagenser og instrumenter såvel som kvalitet.dokumentation af udviklingsarbejdet sker i henhold til de myndighedskrav, der stilles til IVD produkter. Afdelingen samarbejder tæt med beslægtede udviklingsfunktioner i Glostrup og USA. Udvikling af reagenser til IHC. Produkterne omfatter alle reagenser, der er nødvendige for den immunhistokemiske procedure Integration af reagenser på vores instrumentplatforme Udarbejdelse af dokumentation, herunder produktspecifikationer og rapportskrivning Aflæsning af immunhistokemisk farvede præparater Deltagelse i projektarbejde Test planlægning i tæt samarbejde med laboranter Samarbejde med patologer og patologilaboratorier i ind og udland You should have experience in a similar role. Selvstændig og skaber fremdrift med fokus på målet Stærk kommunikator Team player Akademiker til udvikling af reagenser og systemer indenfor molekylær patologi Dako fokuserer på udvikling af nye systemer til anvendelse i diagnosen af cancerpatienter. Vi søger en person, der kan styrke vores aktiviteter indenfor udvikling og validering af reagenser, herunder at de er nemme og sikre at anvende i de patologiske laboratorier. Design og udvikling af prober til fluorescence in situ hybridisering (FISH) og chromogen in situ hybridisering (CISH) Ansvar for verifikations og valideringsaktiviter for produkter til cancerdiagnostik, herunder protokoller og rapporter Ansvar for eksperimentelt arbejde i laboratoriet Samarbejde med funktionens øvrige medarbejdere, herunder samarbejde om udvikling af automatisering og/eller klinisk validering Samarbejde med eksterne partnere i ind og udland (begrænset rejseaktivitet kan forekomme) Du er molekylærbiolog, biolog, humanbiolog, ingeniør eller tilsvarende, gerne med en PhD grad Du har evne og lyst til at arbejde både i laboratoriet og med dokumentation. Du har erfaring med dokumentation af udviklingsarbejde, herunder verifikation og validering. Du behersker engelsk på forretningsniveau Du arbejder selvstændigt og systematisk og taber ikke overblikket i pressede situationer Du befinder dig godt ved at arbejde i et team om fælles løsning af opgaver og besidder gode samarbejdsevner Du har erfaring med og praktisk kendskab til in situ hybridisering Du er energisk og har stort drive Du er kunde og resultat og forretningsorienteret
3 Akademisk medarbejder. Vi søger en engageret og udadvendt akademisk medarbejder, der kan være fagligt bindeled mellem Persondosimetrilaboratoriet og de to sektioner Industri, Forskning og Miljø (IFM) samt Medicinsk anvendelse (MED) ved Statens Institut for Strålebeskyttelse. Persondosimetrilaboratoriet leverer dosisovervågning af arbejdstagere, som udsættes for ioniserende stråling i deres arbejde og, på den baggrund, prioriterer og forvalter IFM og MED tilsynet med arbejdstagere og virksomheder. Du skal i samarbejde med dine kolleger Sikre en høj og relevant faglighed i forbindelse med instituttets registrering af, og opfølgning på dosisindberetninger. central i etableringen og driften af et nyt register: Statens Register for Persondosimetri (SRP). ansvarlig for at opdatere registreringer i SRP, udarbejde SRP årsrapporter, varetage den tilhørende drift samt udføre den nødvendige kvalitetskontrol med systemet. videreudvikle og konsolidere bestemmelse af interne doser i tæt samarbejde med vores Miljølaboratorium og medarbejdere fra instituttets øvrige sektioner. Parallelt med disse opgaver kan du blive inddraget i andre arbejdsopgaver i Miljølaboratoriet, og i SIS myndighedsopgaver generelt. Højere naturvidenskabelig uddannelse som f.eks. cand. scient., ingeniør Du skal demonstrere selvstændighed og initiativ, have gode eller tilsvarende.det kan være en fordel hvis du har kompetencer inden samarbejdsevner og kunne arbejde systematisk og struktureret for flere af følgende områder: under frie rammer. Du skal endvidere have gode Projektarbejde formidlingsmæssige kundskaber på dansk i skrift og tale. Endelig Laboratoriearbejde sætter vi pris på et godt humør og højt til loftet. Almindelige IT værktøjer samt CRX, database Ioniserende stråling, kemi og fysik Administration og kvalitetskontrol Det vil være et yderligere plus, hvis du har gode engelskkundskaber, interesse for internationalt samarbejde og dermed kan indgå i et eller flere af de internationale faglige fora vi deltager i. Da der varetages myndighedsopgaver i hele landet kan det være en fordel, at du har kørekort. Analysekemiker til alsidige konsulentopgaver I jobbet får du en unik kombination af konsulentarbejde, arbejde med standardanalyser og udviklingsopgaver. I din hverdag vil arbejdet veksle mellem at håndtere kundeforespørgsler, udarbejde analyseprogrammer og analytiske løsninger til vores mange kunder. Samtidig har du dage i laboratoriet, hvor du samarbejder med laboratorielederen på det analysetekniske driftområde. Derudover deltager du i såvel generering af nye som gennemførelse af eksisterende projekter. Du er med til at udvikle vores kompetencer inden for analytisk kemi baseret på væske og gaskromatografi og massespektromeri, og du bliver med tiden en af vores primære kontaktpersoner inden for disse fagområder. Du løser opgaver som analyseteknisk sparringspartner for kunderne i den farmaceutiske industri og miljøindustrien, og du koordinerer den faglige indsats samt bistår kunderne med rådgivning om sammensætning og udvikling af analysepakker og metodevalideringer. Du er uddannet kemiker (cand. scient, kemiingeniør eller farmaceut), og har dokumenteret erfaring med håndtering af kunder fra et kommercielt analyselaboratorium eller rådgivende ingeniørvirksomhed. Erfaring inden for avanceret massespektrometri er en fordel. Ligeledes vil dokumenteret erfaring med kvalitetssystemer såsom ISO og GMP blive vægtet højt. Du brænder for dit fagområde og kan lide kundekontakten og den rådgivende konsulentrolle. Du er en god projektleder, og det falder dig naturligt at prioritere din tid i såvel projekter som i hverdagen. Du er vant til at kommunikere skriftligt på både dansk og engelsk. Analytical Chemist work in our analytical team and assist with Qualitative and quantitative analysis of biological samples performance of bio analytical and pharmaceutical Qualitative and quantitative analysis of pharmaceutical samples services in the company s research and Responsibility for the analytical work in internal and external projects development projects and programs. The work Work according to Camurus quality system and documentation also involves developing, qualifying, implementing, and transferring analytical techniques and methods for internal and/or external use. Most of the analysis is performed using immunoassay techniques, particularly ELISA, and HPLC. Other responsibilities include structural elucidation of unknown impurities and degradation products, analytical support of process and formulation development, and release and stability testing of clinical material and drug products. An analytical chemistry or similar university degree Willingness to work in a fast paced, dynamic, team oriented Experience of qualitative and quantitative analyses using environment immunoassays (ELISA) and HPLC Experience from analysis of biological drug substances such as peptides and proteins Efficient in documenting and writing reports for internal and external use Computer experience, especially from the programs Ms Word and Ms Excel We would prefer that you have been working in compliance with cgmp/glp and other regulatory requirements such as the ICH guidelines. Experience from method development/optimization of immunological methods and HPLC with UV/diode array detection are further merits. Excellent oral and written communication skills in English and Swedish Analytical Protein Chemist The right candidate will provide technical and scientific support for our research, and contribute to the development of Symphogens recombinant antibody mixture products in a dynamic and innovative environment. As part of our Characterization Team, the right candidate will be responsible for various challenges related to characterization of antibodies in our discovery and development projects. We seek a candidate with experience in advanced analytical characterization methods, and the successful candidate will be perfoming analytical work using a range of technologies including UPLC/HPLC, mass spectrometry, and capillary gel electrophoresis. PhD degree or similar in biochemistry or equivalent. Hands on experience with analytical HPLC/UHPLC, including method development Experience with standard analytical methods for protein characterization Experience with mass spectrometry is an advantage but not a prerequisite Experience from biotech will be regarded as an advantage Strong communication and language skills (Danish/English) Self driven, well organized team player with commitment, initiative and a keen sense humor
4 Analytical Scientist for Pharmaceutical Product Support Pharmaceutical Product Support delivers pharmaceutical, analytical and packaging support and documentation for LEO on marketed products. You will work closely with your colleagues on interdisciplinary projects within the LEO organization both in Denmark and globally. stability evaluation of marketed products to write and update quality documentation for regulatory purposes in connection with projects, questions from authorities, renewals and applications for variations to participate in projects across the LEO organization in Denmark, Ireland and France to plan and conduct analytical development and support to prepare analytical validations and procedures You hold a Master of Science in Pharmacy, Engineering or Chemistry. You have a minimum of 3 years of experience within analytical chemistry and stability testing and you have previously worked in a similar position or as an CMC coordinator. Experience within development, validation and implementation of HPLC methods are an advantage. Fluent in Danish and English, written and oral A solid understanding of GMP will be considered an advantage as we work in accordance with current GMP regulations. you enjoy project work and are able to handle a large number of different tasks simultaneously. completing tasks and projects within deadlines responsible, systematic and a competent decision maker service minded and flexible striving to improve processes within the team and for projects able to work both independently and as a team player taking on responsibility in project work fluent in Danish and English, written and oral a good colleague who cooperates well with others and consider it important to have fun at work good at knowledge sharing You are good at prioritizing assignments and structuring your time and you thrive in an environment where days are never alike. Application and Support specialist for our high end products. The successful applicant will have technical, application and support responsibility for our high end products from Eppendorf and New Brunswick, in the Nordic region That involves installation, costumer training, application support and pre sales demonstrations. You will be working closely together with the Nordic product manager concerning instrument applications, maintenance and repair.administrative tasks involve reporting in Eppendorfs CRM system, on line customer support and marketing activities. Eppendorf Nordic will employ you with a fully equipped home office with all expenses paid. You should expect +60 travelling days per year. BA degree in Life Sciences or equivalent. Minimum 3 years working experience in capital equipment in the BioPharma market preferred Fluent in English with good understanding of Scandinavian languages. The successful applicant has practical laboratory experience in programming and configuration of laboratory equipment. Extensive knowledge of various standard assays involving pipetting and automation, e.g. ELISA, RIA, PCR or Q PCR. Sales experience is an advantage, since the position is regarded equally technical and commercial. You have an independent, proactive and decisive nature. Self motivated with excellent time management skills. You have excellent interpersonal and communication skills and high technical understanding. High drive coupled with the ability to work through and with other team members and have the ability to build strong networks and relationships Applications Scientist Support Microlytic s sales and commercialization efforts through in house and external applications development projects, workshops and onsite customer support. Start up applications training and continued applications support to customers in their laboratory Direct management and coordination of projects with Microlytic s collaboration partners Provide technical assistance to customers through direct interaction in person, via phone and Training of the sales team on new and existing products and on the latest developments in the structural biology field Work independently and with our sales force to drive the sales of Microlytic s portfolio in a technical and consultative manner based on scientific applications Assist in the launch of new products, services and instruments by developing PowerPoint presentations, training sales representatives, performing demonstrations and seminars. Monitor the competitive landscape and provide analysis of key findings to senior management Perform in house product and protocol development for existing Microlytic offerings Identification and development of new products and services Ph.D. in Structural Biology, Biochemistry, or related field Minimum 5 years lab experience with proven knowledge, understanding and success in protein X ray crystallography Excellent oral and written communication skills Experience in presenting technical materials in written and verbal form is critical Ability to effectively work on and manage many priorities at one time A supportive and approachable team player Must be self reliant and a self starter
5 Associate manager Are you ready to lead a team of highly specialised Set direction for your team and maintain high quality standards and skilled colleagues? In Biopharm API mammalian cell production in Hillerød you will join a department of 100 colleagues, have a group of Associate Manager colleagues and head your own team. We produce Haemophilia API and have responsibility for product quality until delivery to our filling plant. We are on the point of manufacturing to market. You will play a key part in helping people with Haemophilia all over the world. As Associate Manager you will head and direct a process support team of approximately 20 motivated professionals primarily Technicians and Chemists. Your overall objective will be to make sure that our production support lives up to our high standards and regulations. In cases where production deviates from standard, you promptly make sure to handle the deviations correctly according to quality procedures. As such, you will need a team of highly qualified and motivated colleagues. It is your job to shape a working environment that creates job enthusiasm and matches the requests and capabilities of your team. For this you set up KPIs and follow up accordingly to make sure that behaviour and results are correctly measured. You set an example and point the way, and you take pride in securing a high quality in everything you do. You have solid managerial experience combined with a Master s degree In this way you focus on the targets and have the will and the in one of the natural sciences and have acquired a sound understanding skills to fulfil them. You thrive in the decision making role where of the production set up. You are highly familiar with quality standards decisiveness, self consciousness and conflict management are and know when to react to maintain the correct output. If you know key words, and you know how to win acceptance through direct the pharmaceutical industry, it will be a plus. LEAN, GMP and ISO9001 and clear communication. are natural elements in your workday, and you have a keen eye for improving and optimising your own and your team s working conditions and procedures. Bioanalytical Scientist The CFB focuses on developing the next To be responsible for the design of high throughput analytical methods generation of cell factories deploying advanced To participate in the planning and setting up of new laboratory facilities and metabolic engineering techniques, and the the development of high throughput targeted analytical platforms development of bioprocesses for a sustainable To be responsible for and maintain the targeted analytical platforms production of chemicals and therapeutic proteins. To assist in set up, evaluation and coordination of the activities and to take main responsibility regarding instrument maintenance Analyse data, prepare reports and discuss results with collaborators To actively participate in networks and collaborations within the Center and the surrounding research community To supervise junior staff Handle and report experimental data in reports, lab notebooks and LIMS systems A PhD (or equivalent) in Chemistry, Biochemistry or related discipline and several years of practical experience from industry or academia Proven experience in chromatography method development, instrument maintenance, small molecule quantification & high throughput analysis Experience in reporting in lab notebooks and/or LIMS systems Computer proficiency (Word, Excel, PowerPoint, LIMS) Excellent communication skills both oral and written Previous experience in working with protein analysis and identification in a high throughput environment will be considered a distinct advantage Flexibility, enthusiasm, responsibility, team spirit and excellent collaboration skills Business Development Representative The primary objective will be seeking out and building quality relationships with clients. You will have support from our Senior Scientists throughout the process from developing the proposal to closing the sale The position will require you to interact extensively with the company's scientific staff, Executives and Client Services Departments. Day to day tasks include establishing contact, visiting and communicating with clients and potential new clients. The job entails up to 50% travel, including attendance at conferences and exhibitions. Preclinical experience, knowledge of drug development are an advantage but people with other relevant experience could also apply Prior CRO experience Experience selling highly technical scientific service Demonstrated success in selling services Fluent in English and either Danish or Swedish We are looking for a highly entrepreneurial individual with experience selling to Pharmaceutical and Biotech companies Cand.scient. eller ingeniør til udvikling og rådgivning inden for medicinsk bioteknologi I samarbejde med vores forskningspartnere og Du skal arbejde med kunde og teknologiudvikling inden for mikrobiologi og industrielle kunder skal du være med til at bringe medicinsk bioteknologi. Sektion for Medicinsk Bioteknologi arbejder sammen nye teknologiske muligheder til praktisk med både universiteter, hospitaler og biotekvirksomheder med mange typer anvendelse i industrien. Fokus er således at bringe projekter, herunder bl.a. udvikling af diagnostiske værktøjer inden for den nyeste viden ud til vores samarbejdspartnere psykofarmaka, infektioner og cancer, undersøgelse af lægemidlers effekt samt gennem forsknings og udviklingsprojekter. Vi har udvikling af prøvetagningskit og skræddersyede forsøgsopstillinger. faciliteterne, der giver mulighederne. Du er cand.scient. eller ingeniør inden for biokemi, molekylærbiologi eller lignende, gerne suppleret med en ph.d. Det er en fordel men ikke et krav, hvis du har: Praktisk erfaring med proteomics, dataanalyse og bioinformatik Erfaring med mikrobiologi og tilhørende molekylærbiologiske metoder Kendskab til projektgenerering, projektledelse og håndtering af udviklingsopgaver Erfaring med kundekontakt og rådgivning Gennem din åbenhed og evne for at få nye idéer, er du i stand til at identificere nye projektmuligheder inden for proteomics. Du er fagligt kompetent og er indstillet på at arbejde fagligt bredt i tæt samarbejde med dine kolleger og vores partnere i virksomhederne, på universiteterne og i offentlige institutioner. Desuden trives du i et dynamisk arbejdsmiljø, hvor opgaverne sjældent forløber og løses som forventet Chefkonsulent til agroindustri og fødevareteknologi Stillingen er placeret i området for Brancher, Funding og Analyse, her skal du samarbejde tværfagligt med 20 dygtige kollegaer med meget forskellig baggrund, i afdelingen Branchesekretariater. Som medlemsansvarlig chefkonsulent får du et selvstændigt job med tæt medlemsdialog. løbende medlemsdialog politisk servicering af de agroindustrielle medlemmer udvikle og implementere medlemstilbud, bl.a. fælles eksportaktiviteter at rekruttere nye medlemmer relevant akademisk/faglig baggrund Som person er du åben, samarbejdsorienteret, idérig og ser det nogle års erfaring fra jobmarkedet som positivt, at der vil være rejsedage. kommerciel indsigt gerne fra ansættelse i virksomhed med salgsansvar international erfaring forståelse for organisatoriske sammenhænge og politiske forhold erfaring fra projektledelse og samarbejdsprojekter.
6 clean Project Manager Does your profile mirror an education within natural sciences and experience from working with optimisations in a research and/or product development organisation? If so, you now have the opportunity to join a strong department that has been working professionally and successfully with LEAN, Six Sigma and the like for 6 years. You will join us on our way towards new successes in the name of process optimisations and improvements. We are part of Novo Nordisk Diabetes Research Unit (DRU) in Måløv, Denmark counting 800 scientists and technicians. Our goal is to streamline the research processes so the DRU organisation can gain more time for innovation in the overall fight against diabetes. You will be part of an agile team together with the manager of the DRU LEAN department and one additional scientist/lean project manager. Your focus is to identify, plan and implement improvement activities across the Diabetes Research Organisation that is working with the discovery of new drugs. The headline for your work is: engaging people across our sites in Denmark, China and the US. You make your research colleagues understand the enormous value gained by improving our processes. To do so you must gain indepth understanding of the research processes and combine this with your knowledge within process improvements. From project to project you will consider which tools might be the best in order to engage people. You organise workshops in close dialogue with local managers, describe new processes, develop and present PowerPoint presentations, participate in the further development of the LEAN training program. You have an education at minimum master s level within natural sciences and you have hands on experience from working in a research and/or product development organisation. You therefore have a good understanding of the processes and methods that characterises this special working environment. In combination with your interest in optimisation and your knowledge within e.g. LEAN and change management you can see the potential and personal development opportunities in this position. To succeed you will need a strong drive for results and the will to develop creative and innovation solutions founded in your organised and systematic working approach. These skills also make you a born Project Manager, no matter if you are the primary driver or a team member in a project. At the same time you are a strong communicator and you can create a stringent and catchy PowerPoint presentation and deliver it to a large audience. In relation to this, you can build and develop relations to a large number of contacts at all levels in the organisation. Finally, you thrive on using your coaching skills to engage and motivate people around you. Clinical Pharmacologist You will be responsible for the planning, execution and reporting of clinical pharmacology studies within the therapy areas of diabetes and obesity. You will interact with many internal and external stakeholders worldwide and have the opportunity of doing something extraordinary in clinical medicine through this position in Novo Nordisk A/S. Your primary tasks will be to prepare, execute and report clinical pharmacology studies through preparation of study protocols and other relevant study documentation, chairing study groups, interaction with investigator and CRO, involvement in data cleaning/evaluation and reporting of the study results. You hold a university degree within relevant area, e.g. MSc, MD, veterinarian, or dentist preferably supplemented with a PhD. Competencies in drug development, particularly clinical pharmacology, is required. Furthermore, project management skills and experience within or related to the therapy areas of diabetes and obesity will be required. Analytical mindset and keen sense of quality are vital for the position. Interaction with many internal and external experts requires team spirit, good communication, coordination and planning skills, as well as flexibility and proficiency in English Clinical Project Leader I klinisk afdeling er vi ansvarlige for at koordinere kliniske studier i samarbejde med vores amerikanske kolleger for samtlige forretningsområder. Som del af et transatlantisk, klinisk projektteam vil du få mulighed for at lede de europæiske studier af medicinsk udstyr fra start til slut. I den forbindelse skal du være indstillet på at rejse 3 6 dage om måneden. Ansøge myndigheder og etiske komiteer om tilladelse til at udføre kliniske studier Koordinere kontrakter indgået mellem Cook Medical og de samarbejdende hospitaler Aflægge opstartsbesøg hos de deltagende centre, sikre udførelse i henhold til protokollen, gennemgå monitoreringsrapporter og medvirke til styring af afvigelser Notificere myndighederne om studiets udvikling samt anmelde uønskede bivirkninger Etablere tætte arbejdsrelationer til læger, deres forskningspersonale og eksterne konsulenter gennem god og regelmæssig kommunikation Lede interne såvel som eksterne studieteammøder Fungere som bindeled mellem sponsor, det kliniske team og de deltagende centre Være ansvarlig for at nå studiets mål ved at samarbejde med teammedlemmer for at fastsætte projektets prioriteringer og milepæle Reagere prompte og hensigtsmæssigt på studierelaterede spørgsmål, der opstår på de deltagende centre eller hos sponsorer, monitorer og læger En relevant akademisk uddannelse fx cand.scient, cand.polyt. eller cand.agro Erfaring fra tidligere kliniske afprøvninger (min. 3 år), helst inden for medicoindustrien Praktisk erfaring med ISO 14155, MDD, GCP, FDA og andre myndighedskrav Flydende engelsk i skrift og tale (koncernsprog) Vi søger en engageret og målrettet kollega, der har erfaring med udførelse af kliniske studier. Vores miljø er inspirerende og til tider hektisk, og der vil være rig mulighed for både faglig og personlig udvikling. Vi ser gerne, at du er en udpræget teamplayer med en assertiv og løsningsorienteret tilgang. Det er en selvfølge, at du arbejder selvstændigt med dine egne ansvarsområder og trives i et internationalt, dynamisk miljø
7 Clinical Representative You customer groups will be hospitals in Denmark which requires cross country travel where you plan and execute education, product training and other customer activities and initiatives in the territory. You maintain close customer relationships at all levels and in doing so you identify, drive and execute product opportunities within existing or new customer groups in close cooperation with the Key Account Manager in Denmark. Your main focus will be clinical training and certification of PCI cardiologists, Interventional Radiologists, Vascular Surgeons and Nurses. Thus you need to feel confident in a hospital environment, and in a cathlab. You also need to feel comfortable in educating, advising and consult physicians and healthcare professionals in order to train and certify them in usage of the device. We want you to have an interest in diagnostic and interventional cardiology and radiology as You will be in the operating room with patients and medical professionals proving guidance and feedback. To fulfill this role you have experience from cath. lab and hospital environment preferable working with VCD. You have an academic or medical background e.g. as a nurse with hands on experience within cardiology or radiology. Experience from the medical device industry is a plus but you can also come directly from a hospital setting. Likewise pedagogical experience from leading educations and/or trainings, either in the industry or in a hospital setting, is a plus. You also need to be fluent in Danish and English, both verbally and in writing As a person you have excellent interpersonal skills and strong hands on approach, you are a doer. You have an open, flexible mindset with ability to prioritise and to travel extensively, in Denmark, occasionally international. Clinical Research Associate You are able to have the greatest impact on drug We are seeking independent professionals who also have the ability to see the and medical device clinical trials by working onsite with the clients and focusing on the clinical attention to detail, are able to build lasting relationships with internal and big picture and communicate effectively. If you are organized, have strong trial while leveraging the resources on our inhouse monitoring team. Because of our unique new face at PAREXEL external clients, and excellent communication skills ' we want you to be the structure, you are able to spend less time on the administrative aspects of the trial and will be able to focus on what you were trained to do develop close relationships with the sites and have a positive impact on the success of the trial. Fluency in Danish and English Experience monitoring clinical trials in Denmark Able to travel a minimum of 65% on average Holds a driving license where required Clinical Research Associate En CRA inom Smerud Medical Research har ofta ett helhetsansvar för den svenska delen av projektet huvudsakliga kontaktperson gentemot kund, och att arbetsuppgifterna förutom monitorering och hantering av studiedokumentation omfattar t.ex. ansökningar till etikprövningsnämnd och myndigheter, utveckling av patientinformationer, biobanksfrågor och ekonomiska avtal. har en naturvetenskaplig högskoleutbildning, kompletterad med kurser på området kliniska prövningar har några års erfarenhet av att arbeta med monitorering och klinikkontakter i rollen som CRA eller klinisk prövningsledare är väl förtrogen med ICH GCP och det svenska regelverket kring kliniska prövningar har mycket goda språkkunskaper i svenska och engelska både muntligt och skriftligt har B körkort och är beredd att resa i tjänsten En CRA inom Smerud Medical Research har ofta ett helhetsansvar för den svenska delen av projektet Vi ser gärna att du har tidigare erfarenhet av detta. har förmågan att snabbt sätta dig in i ny information och arbeta självständigt har den flexibilitet och prioriteringsförmåga som krävs för att hantera flera studier parallellt CMC Manager, Global Regulatory Affairs We are looking for a Regulatory CMC Manager who has the ambition to work in a dynamic and international environment. The CMC Development department is part of Global Regulatory Affairs, Roskilde, Denmark. (CMC: Chemistry, Manufacture and Control).The position is a specialist position requiring pharmaceutical technical experience as well as knowledge of regulatory processes. We are looking very much forward to hearing from you, if you can see yourself in the profile described below. Responsible for the pharmaceutical technical documentation (module 3 and 2.3) for new applications and for life cycle activities for existing products Provide regulatory advice for content of CMC documentation to be provided in actual regulatory case (application, response etc) Coordinate and drive document preparation to ensure deliverables according to agreed deadlines Preparation and review of pharmaceutical technical documentation Close Co operation with Manufacturing sites, Development teams and Regulatory Affairs managers Be up to date on regulatory requirements for the CMC area Experience with preparation and review of technical documentation (module 3 and 2.3) for regulatory approvals of medicinal products for human use Experience within pharmaceutical industry and/or Health Authorities Have ability to create overviews and communicate it for colleagues Establish and comply with realistic deadlines High level skills in English (orally and written) Well experienced IT user (Word, Adobe and preferably document management systems (EDMS)) Scientific Master degree Works independently and pro actively in a complex environment with different processes and solutions Flexible and team player Optimistic and open minded Coordinator and communicator
8 Commercial Manager/Business Development Manager Novo Nordisk Foundation Center for Biosustainability er et nyt forskningscenter startet i 2011, som forsker i at udvikle nye biobaserede og bæredygtige teknologier til fremstilling af fremtidens kemikalier til erstatning for den nuværende ofte oliebaserede kemikalieproduktion. Senest har CFB udvidet sine aktiviteter til at indeholde CHO cellebaseret produktion til udviklingen af næste generation af biofarmaceutika. Du bliver en del af Centrets Business Development enhed med reference til Chief Business Officer Vurdering af anmeldte opfindelser, herunder: o Videnskabelig due diligence (proof of principle, proof of concept mv.). o IP due diligence (beskyttelse af opfindelse). o Kommerciel due diligence (nyttiggørelse af forskningsresultater). Udvikling af forskningsplan, herunder: o Sikre værditilførsel til research teams samt platform for tværfaglige forskningsprocesser. Udvikling af kommerciel plan/business case bl.a. ved hjælp af kommercielle databaser, herunder: o Opstilling af projektets IP platform. o Opstilling af projektets kommercialiseringsplatform. o Opstilling af partner assessments. o Opstilling af potentiel funding struktur. Varetagelse af den juridiske behandling af samarbejdsaftaler og forskningskontrakter (i samarbejde med Business Development enhedens juridiske medarbejder). Varetagelse af kommercialiseringsproces. Administration af aktive porteføljeprojekter. 'Forbindelsesofficer' til erhvervslivet, fonde og eksterne forskningsprogrammer. Præsentation af business cases til potentielle licensees og investorer. Præsentation af porteføljeaktiver til potentielle eksterne samarbejdspartnere på partneringkonferencer og møder. Har en længere naturvidenskabelig uddannelse f.eks. en kandidatgrad i molekylær biologi, bioteknologi, kemi, biokemi, farma eller lignende. Gerne suppleret med en Ph.d. grad eller en MBA eller HD. Behersker dansk og engelsk skriftligt og mundtligt på forhandlingsniveau. Har flere års erhvervserfaring fra Life Science industrien eller en konsulentvirksomhed indenfor Life Science. Har erfaring med business development i en pharma, biotekvirksomhed eller som konsulent til disse. Har erfaring med etablering af start up selskaber. Gerne interesse for og indsigt i IP. Har dokumenteret forretningsmæssig forståelse. Gerne kendskab til kommercielle databaser og brug af disse. Har erfaring i at samarbejde med både danske og internationale eksperter i patentering og kommercialisering. None Competency Development Manager We are currently looking for a new colleague in the Trial Management Anchor which is part of Trial Execution a team of 19 employees. The responsibility of the Trial Execution department is to support, develop and facilitate operational process optimisation as well as competency building within medical and trial management globally. You can look forward to a position in which you are in contact with a wide range of Novo Nordisk colleagues around the world. As Competency Development Manager, you will develop and facilitate the operational skills of trial management staff within clinical trial planning and execution. Together with your colleagues, you will drive and support clinical operational trial process optimisation and competency building. For example, you will be responsible for leading a global team for developing and implementing surveys for site staff and other relevant stakeholders. You will be member of the SOPCouncil and responsible for TMAnchor SOP review. Moreover you will be subject matter expert in the interface between safety and trial management. In addition to this, you will be leading and/or member of global cross functional working groups focusing on process optimisation and productivity gains and act as trainer on courses delivered by Trial Execution as needed. You hold a relevant academic degree e.g. life science, bioscience or other equivalent education. Your track record reflects several years of managing global clinical trial as well as detailed knowledge of planning and conducting trials preferable also from an affiliate perspective. You are considered an expert in your area while still having the broad overview and insight into the entire drug development life cycle. You are experienced and capable of leading cross functional teams and projects and have a keen interest in improving clinical trial operational processes. You have excellent tutoring, communication and presentation skills. You have an interest in IT and excellent computer skills. It is essential that you can act independently, but also as a natural team player who thrives being a successful contributing member to any team you are a part of. You are flexible, change prepared and have a proactive mind set. Compliance & Process Specialist, Clinical Development Support We are offering a challenging position as Compliance & Process Specialist within Clinical Development Support (CDS). You will be part of a dynamic staff function dedicated to supporting the global clinical community within Ferring by optimising systems, processes, procedures, tools and training. Manage the operational Public Disclosure process of clinical trials and results Develop and update Corporate SOPs for Clinical R&D including training and development of training material Co ordinate e.g. the Publication review process and the Investigator Initiated Trials review process or other processes within the scope of CDS Participate in surveillance of international regulatory guidelines and regulations and provide GCP advice to the organisation Participate in cross organisational working groups and general tasks and projects related to CDS Set up and manage working groups as necessary and conduct training within areas of responsibility We expect you to hold a Master or Bachelor Degree within life sciences with ideally at least 3 years experience within clinical trials and experience from a similar position. In addition, thorough knowledge within GCP, applicable regulations and clinical development processes is essential. As a successful candidate, we expect you to have documented project coordination skills, excellent communication skills and fluency in English. In addition it is essential that you are well structured, quality minded with attention to detail, pro active and flexible as well as you are an effective problem solver and result oriented team player being keen on working in a staff function with multiple contacts within a changing and evolving company.
9 Control Engineer As Control Engineer you will be responsible for control and automation of BioGasols process equipment. Development of control logic together with process experts and mechanical engineers SCADA/PLC control system program (we use Siemens STEP 7) Determining machine control strategies and documentation for automation engineering Human Machine Interface (WinCC Flexible) incl. remote access Data acquisition and data exchange Coordination of electrical documentation and building of panels Operation of test plants Commissioning of process plant equipment You will be expected to travel domestically and abroad for approx. 30 days a year for commissioning of plants, where you will have the responsibility for the machine control and electrical engineering incl. integration of BioGasol SCADA into customer plants. You have a M.Sc. or B.Sc. degree or similar in mechanical or electrical control engineering. You have several years of experience within development of industrial process equipment control and automation within i.e. the chemical, oil & gas, energy, agricultural, pharmaceutical or food industry. Other relevant qualifications could include skills within electrical engineering, electrical design, mechanical engineering, mathematical modelling, model predictive control (MPC), data acquisition (i.e. databases), programming (i.e. C++, C#, Visual Basic), process chemistry and energy systems. As a person, you are a responsible team player who works thoroughly, structured and efficiently. You are excellent at coordinating activities within a specific project and at any time maintaining control of your area of responsibility. English language at negotiation level is required, as most of our partners and customers are abroad and you must be fluent in both written and oral Danish. CRA Monitor clinical trials conducted in Denmark as part of international projects. Responsibilities will include determine protocol and regulatory compliance on Bachelor's or higher graduate degree in a science related field, licensed the sites. You will perform and coordinate all aspects of the clinical monitoring or certified health care training or equivalent experience process from "start up" to "close out". You should thrive in multi national Basic medical/therapeutic area knowledge and medical terminology project teams and be focused on delivering exemplary levels of customer preferred service. Senior CRA's will have the opportunity to mentor less experienced staff and experience of Phase II to IV trials, you will have in Phase II to IV trials PPD is a leading global contract research organization providing discovery, development and post approval services as well as compound partnering programs. None Deputy Local Safety Officer Act as the Qualified Person related to the manufacturing/import authorization Release of products imported from non EEA countries Handling of complaints and recalls Creation and maintenance of written procedures Handling of GMP/GDP audits and inspections Act as deputy Local Safety Officer including: Handling of adverse reaction reports on and maintenance of written procedures A 5 year University Degree Preferable Pharmacy (M.Sci. Pharm) A minimum of one year experience from production, QA or QC Experience from pharmacovigilance/adverse reaction reporting is an advantage Fluent in English and at least one Scandinavian language As a person you are structured, detail oriented, and persistent. You are a team player with a positive attitude, enthusiastic, service minded and outgoing. Furthermore, you are used to working with colleagues at all levels and sharing best practice. You take ownership and work independently with personal Deputy manager BioAdvice is a successful preclinical contract research organization (CRO) located in excellent facilities in the heart of Medicon Valley only 30 minutes drive from Copenhagen International Airport. The company has served the pharmaceutical industry for more than 10 years and has GLP and GMP authorization, laboratories and facilities for mice, rats, rabbits, guinea pigs, pigs, minipigs and dogs. Our prime qualifications are qualified advice concerning studies, fast and flexible implementation of protocols, performance of studies and issue of reports to assist and save time for the R&D departments. The position is new and the chosen candidate will therefore have good opportunities to influence and form many aspects of the job, including a profound influence on the future development of BioAdvice A/S. The remuneration package will reflect the responsibility and seniority of the job. Qualified and approved veterinary doctor in Denmark. Experience in preclinical services for the pharmaceutical industry. Extrovert personality active in a consultative dialogue with clients. Experience as speaker on conferences and a list of publications on animal studies published in qualified journals. International experience and English on a high level. Management experience.
10 Development specialist in polymeric controlled release system QPharma is a contract developer and Pharmaceutical Development group is now looking for a specialist in manufacturer of pharmaceuticals and is based in development of polymeric controlled release systems. Malmö in southern Sweden. Our manufacturing plant and development labs have successfully met both national, EU and FDA inspections. We employ around 100 employees and service top 10 international pharmaceutical customers and small innovative Development knowledge focussed upon drug release associated to polymer controlled release devices (min. 5yrs). Polymer based university degree. Practical expertise in scale up from development to an industrialised scale. Know how about needed equipment for production of polymer controlled release devices (as extrusion and injection moulding). Aligned with the fundamentals of QbD (DoE, MVA, risk management) Pharmaceutical experience in terms of experience in working within a cgmp environment. Humor and team work are important elements in you work day Director of Analytical Support As Director of Analytical Support, you will be part of the global Technical Operations team. The Technical Operations team consists of 6 employees, all reporting directly to the Senior Vice President of Global Technical Operations. The function handles all aspects of CMC, implementation of Commercial Supplies and Intellectual Property. The new position involves significant interaction with external partners globally. The new director will work in close cooperation with the other members of the Technical Operations team as well as the Quality Assurance and Regulatory Affairs teams. Preparation of analytical regulatory documentation and responses to regulatory questions Review of analytical data and documentation for validation, stability and release of LCP Tacro Stability testing management Management of external analytical laboratories Implementation of commercial product testing Management of analytical tech transfer between external analytical laboratories Analytical troubleshooting University degree (candidate) with focus on analytical chemistry (biochemist, analytical chemist, pharmacist or similar) Experience with analytical testing of pharmaceutical products Strong sense of GMP Experienced user of Microsoft Office including Word and Excel Good communication skills in Danish and English both verbally and in writing You prosper from working and communicating with your colleagues who are multicultural and sometimes with base in different countries. Drug Safety Advisor You will be assigned your own products portfolio, We in the Drug Safety Evaluation team are one of three groups in and will be responsible for the overall safety Pharmacovigilance, Copenhagen. Some of our main responsibilities are to evaluation of those, as well as the timely write, submit and review PSURs. preparation and submission of reports. In your Prepare Company Core Safety information and answer assessment Reports daily work, you will be in close cooperation with from the authorities. Perform Signal Detection and prepare Risk Management our other departments and affiliates as well as the Plans. authorities in many different countries. You will be assigned to various projects and process optimization e.g. participate in implementation of new PhV legislation and guidelines. You have a master degree in medicine, pharmacy, human biology or equivalent scientific background Minimum 2 years of experience from a similar position You have a good level of knowledge of general medicine and pharmacology You work towards common goals and have the ability to influence others
11 Experienced Internal GMP Auditor You will report to the Associate Director Drug Compliance in Boston US and you will be a part of a dedicated team of 4 colleagues. This group is a part of Corporate Quality and GMP Internal audit. The position is new and as the new Internal GMP auditor you will be the key individual in securing that audits are planned, conducted, followed up and managed in accordance with procedures as part of a Quality Management System that allows the company to achieve a high standard of compliance with regulatory guidance Contribute to the development and management of the Annual pharmaceutical operations and technology Audit Schedule Schedule, prepare, conduct and report internal audit and compliance monitoring activities to ensure compliance with the company s SOPs and applicable guidelines and regulations in relation to GMP Ensure timely responses to audit observation and the follow up of proposed actions where required Create reports and track follow up of observations using the Track Wise Audit Management System and provide support to auditees required to provide responses through the same system Identify potential risks, areas of process improvement or trends from the various audits and communicate recommendations to management Assist with the development of metrics reports and presentations of outcomes to Biogen Idec business Owners You will assist in regulatory inspection activities as required You might have a Master of Science, Chemistry, Biotechnology, Microbiology or equivalent. You have a minimum of 8 years GMP and Quality Assurance experience cgmp experience in Manufacturing of biologics and/or small molecule drugs You will have at least 5 years of auditing experience in a cgmp environment and has a good understanding of the regulations Medical Device/ ISO experience is a plus but not required Spoken and written English/Danish must be fluent Experienced user of MS Office, Lotus Notes, Trackwise As a person you are working independently and take ownership of your task Experienced Synthetic Chemist We are seeking for an experienced organic chemist at PhD level with excellent synthetic skills and profound interest for preparative synthetic work and technology development. Y Your key responsibilities will be to identify and develop new synthetic routes, procedures and protocols targeting complex carbohydrate motifs and their precursors. You are used to work systematic, targeted and under time pressure from deadlines. You are familiar with a wide repertoire of analytical methods and use NMR, HPLC and MS on a routine basis for analysis. You have a basic understanding and are willing to learn intensely about process, safety and cost sensitivity of large scale production. Hold a PhD in the field of Synthetic Organic Chemistry, ideally with experience in Carbohydrate Chemistry and/or development work gained in an industrial environment Have excellent synthetic skills and a strong knowledge of relevant analytical methods Are constantly striving to increase your personal and professional qualities Speak fluently English and have strong interpersonal skills Have a profound wish to become part of one of the most innovative companies in Europe Fermentation scientist Our department delivers scientific support to Diabetes API manufacturing and carries out small and large projects in order to optimise quality, capacity, and costs. Other tasks are carrying out process challenges, up scaling and transferring of new products to industrial manufacturing.you will be a part of the Insulin Manufacturing Support team, consisting of 9 scientists and 9 laboratory technicians. The team is supporting the diabetes API factories in Kalundborg within fermentation, recovery, and purification You will be responsible for acute scientific support to the manufacturing factories, and acting as sparring partner for production colleagues with regards to root cause investigations. You will also be planning, executing and documenting pilot fermentations and other laboratory experiments; and you will be responsible for up scaling during transfer of new processes to industrial production. You will be carrying out your work and projects with sharp deadlines without compromising the quality of your work. In order to meet your deadlines you will be collaborating with a broad range of colleagues from manufacturing, project management, QA, analytical laboratories and regulatory affairs You hold a relevant scientific degree and have solid knowledge about fermentation processes combined with industrial hands on experience, and you have already used your competencies to solve various practical challenges with fermentation processes. You are capable of using your scientific knowledge to trouble shoot and identify optimization initiatives that can contribute to a continuous improvement of our manufacturing processes. It is an advantage if you understand the interrelation of fermentation, recovery and purification processes in a biological manufacturing process. Preferably you have experience with GMP documentation and participation in audits from authorities and internal QA. You have a social, positive and outgoing mind set enabling you to build fruitful networks and relations to colleagues and partners, and you are capable of working both individually and as part of a team. You prefer a dynamic atmosphere where changes occur on a short notice, and you respond constructively to challenging situations. You are a strong communicator both orally and in writing, in Danish and English, who is capable of creating a common overview of complicated situations. Formulation scientist Novozymes Biopharma DK A/S, an integrated part of Novozymes, is seeking a formulation scientist for a one year position with experience in protein drug formulation You will work in the Biopharma Formulations and Applications team, focused on building up product application know how and evaluating the performance of our recombinant ingredients and related technologies for pharmaceutical formulations and drug delivery. MSc in protein drug formulation or a related subject with 1 3 years additional research experience potentially combined with a PhD You have practical experience of formulation techniques and characterization and protein based formulations You are used to working with standard analytical techniques such as HPLC Experience with Design of Experiments and knowledge of Quality by Design concepts would be a distinct advantage Excellent communication skills in English are a prerequisite You are an enthusiastic self starter with an experimental and hands on approach and you like working in the laboratory You are committed, innovative, open and a solidary person with good networking skills
12 GCP Advisor The job offers exciting challenges in developing and maintaining our quality management system, with a strong focus on GCP and compliance globally. You will together with 12 colleagues be responsible for supporting the Novo Nordisk Quality Management System and to develop the department further into being a quality department. You will manage cross departmental working groups and you will provide training and advice. You will participate in a crossfunctional IT project ensuring a full electronic handling of Non Conformities incl. CAPA and Change Control processes globally in Novo Nordisk A/S. Further you will be overall responsible for ensuring the handling of our CT SOP deviation system. You have a degree in science or similar and a strong command of written and spoken English. You have at least 4 years experience in clinical research and drug development, as well as solid knowledge of GCP. Experience with clinical quality assurance and project management is an advantage. You have an interest in IT and excellent computer skills You take a pragmatic approach to problem solving, and have strong interpersonal skills. You are analytical, organised, detailorientated and quality conscious. You re a team player who thrives working across departments in an international organisation. Global Product Manager The Global Product Manager, will be responsible Product care/product Management for managing the full product life cycle of a range Advanced Staining Solution Lifecycle Management of reagents and kits that form a key part of the Strategic planning Dako Laboratory Solution and support the Market environment and Competitor analysis strategic important IHC Reagent Business. You will Pricing be the primary contact for a number of key Launch planning internal and external stakeholders, such as; R&D, Tactical planning Operations, Sales and Key thought leaders in the Contract management with external vendors field of pathology. Forecasting Planning product availability and distribution Education / Training Technical Master or bachelor degree, additional MBA or similar education is a plus Min. 4 years of experience with product marketing and/or sales Global mindset and experience from working in an international environment Must be fluent in English, oral and writtentechnical Background and good understanding of the diagnostic market Marketing experience as a Global Product Manager of a technical BtB product Experience within the Diagnostic and/or Life Science industry is an advantage Commercial and analytical mindset and ability to drive change High drive and focused on creating results Proactive and good at prioritizing Good at setting your own goals Willing to travel between days per year to understand the market and customer needs and to support global/local business initiatives Proficient communicator and able to work in an international environment and with cross functional groups Global Regulatory Affairs Associate Reporting to the Associate Director, Development Projects you will support the department and work closely with the regulatory managers under their guidance. Preparation, submission and maintenance of all CTAs/eINDs Compilation of amendments, end of trial and trial report submissions to the HA Responsible for compilation of Module 1 and assisting in compilation of the regulatory dossier Responsible for running the labelling procedure during the translation phase under an EU procedure and managing the mock up creation process Assisting in preparing the core prescribing documents (EU, US, Japan) Collecting information and assisting in preparation of regulatory strategies Assisting in planning HA meeting and compiling briefing packages. Documents handling in the electronic document management system and the clinical trial management system Data entry in the Global Regulatory Database hold a degree in Pharmacy, Life Sciences or equivalent have an understanding of GLP, GCP and GMP have excellent IT skills especially with use of Microsoft Office are fluent in English with excellent writing and linguistic skills and preferably speak one of the Scandinavian languages are service minded, action oriented with solution oriented approach and able to deliver high quality work on time enjoy working within a multicultural team and contributes to a good working environment in the department have a pleasant and responsible personality with good sense of humour Global Regulatory Affairs Associate Reporting to the Associate Director, Development Projects you will support the department and work closely with the regulatory managers under their guidance. Preparation, submission and maintenance of all CTAs/eINDs Compilation of amendments, end of trial and trial report submissions to the HA Responsible for compilation of Module 1 and assisting in compilation of the regulatory dossier Responsible for running the labeling procedure during the translation phase under an EU procedure and managing the mock up creation process Assisting in preparing the core prescribing documents (EU, US, Japan) Collecting information and assisting in preparation of regulatory strategies Assisting in planning HA meeting and compiling briefing packages. Documents handling in the electronic document management system and the clinical trial management system Data entry in the Global Regulatory Database hold a degree in Pharmacy, Life Sciences or equivalent have an understanding of GLP, GCP and GMP have excellent IT skills especially with use of Microsoft Office are fluent in English with excellent writing and linguistic skills and preferably speak one of the Scandinavian languages are service minded, action oriented with solution oriented approach and able to deliver high quality work on time enjoy working within a multicultural team and contributes to a good working environment in the department have a pleasant and responsible personality with good sense of humour
13 Global Sales Director Your experience and ability to execute will be crucial for the development and growth of this position. You will shape your own job and be given the opportunity to influence the further development of the company. As the company's first Global Sales Director, you will be responsible and accountable for global sales, in terms of developing market shares, initially focusing on the European markets.you will be given the responsibility for the sale of thorough and tailor made analyses developed for each individual customer. The solutions are aimed at various stages of the drug research and development such as biomarker discovery and optimization, target identification, drug discovery, patient stratification and translational research. You have a Master s degree or the like and extensive business understanding Documented and substantial sales results, at least 5 years of strategic sales experience from a global organisation, preferably from a position with direct sales to the pharmaceutical industry Experienced in selling complex solutions and concepts Strong international profile especially so on the European markets Strong analytical mindset, positive, committed and energetic Able to work efficiently in a busy, dynamic and global environment Communicates and discusses solutions at a high organizational level Excellent communication skills and fluent in English (written and oral) You must be a goal oriented, experienced person with solid knowledge of strategic key account management and focused on the presentation and sale of the corporate concept Global Service Specialist The Global Service Specialist is the company s senior Service Professional for a specific Dako instrument or software solution. Considered the service expert on your product you will be providing support to our service organizations worldwide, perform class room training and onsite training on a global basis as well as seeing to that product serviceability and service documentation are state of the art. Gather market requirements from a field service perspective analyzing needs Thorough technical understanding of diagnostic instruments in order A strong drive and perseverance in order to work in a fast paced and requirements from Dako field service personnel, distributors and customers worldwide to troubleshoot, analyze and resolve technical issues Good knowledge and interest for computer software and network environment Monitor product and service issues and drive problem resolution as a service systems representative in Dako internal forums Very good presentation skills including excellent communication skills Drive product and process improvements towards internal stake holders such both written and verbal, experience as trainer is considered an as QA, Marketing, Supply Chain and R&D Develop the Service Training Program for the instrument as well as plan and execute service training sessions at Dako premises and customer sites worldwide Create and manage service specific documentation such as Service Manuals, advantage Fluent in English and additional languages a plus Bachelor s Degree in Engineering or Science 10 years field service experience, 5 years of experience within life science or diagnostic sector Checklists, Training Materials as well as maintain regular communication to the Ability to travel days per year field Define and manage spare parts, pricing, recommend stocking levels and trunk stock levels Prepare and implement the Service Strategy for the specific instrument also supporting the work of selling Service Instrument Agreements worldwide Global Solution Manager for the Omnis staining solution to Global Market The Global Solution Manager is responsible for product management of the Omnis solution, Dako s coming new product for automated IHC and ISH staining. The Omnis will complement and add to Dako s existing staining portfolio in advanced staining systems, and will be a cornerstone in Dako s product portfolio going forward. Within the Global Solution Manager role, you will have regular interface with a number of key internal stakeholders in Operations, Regulatory Affairs and R&D, and will be responsible for the maintenance and development of these relationships. The role will focus on product management, including product care and product lifecycle planning, and is supported by a Science Agenda team, a Customer Solutions team and a Portfolio Access team. Being a team member in the GMCM organization, your primary responsibilities will be to engage in strategic planning, life cycle management and to oversee the product s strategic and tactical plans. Specific efforts will be dedicated towards Omnis development and product care activities. Based on market trends, customer feedback and sales input you will be responsible for delivering specifications for initiation of new development projects for Omnis within hardware, software and reagents. You will work with our Glostrup based R&D and production team on development projects and product care activities. Additionally, you will be responsible for catalogue/web information, and will support development of new sales support materials. You will also be responsible for forecasting, monitoring sales, carrying out pruning activities, and delivering financial justifications for initiation of new product development projects. Product line responsibility also includes global competitor surveillance, and tracking of product market shares and profitability. Master or bachelor degree in economics, science, MBA or similar education is a plus Min. 3 years of experience with product marketing and/or sales Global mindset and experience from working in an international environment Must be fluent in English, oral and written You have previous commercial and operational experience from a company with a business focused culture and have a proven track record Preferably you have experience from a Health Care related industry Commercial and analytical mindset and ability to drive change High drive and focused on execution and creating results in a fast paced and dynamic environment Proactive and good at prioritizing Good at setting your own goals and direction Willing to travel between days per year to understand the market and customer needs Proficient communicator and presenter, able to motivate and coach in an international environment and with cross functional groups
14 GMP Coordinator Are you ready to be the one securing and enhancing the quality and compliance level of a complex production environment covering various processes and tasks? We are looking for a GMP Coordinator with the skills, knowledge and overview to secure the department s GMP and compliance level, making it ready for inspection at all times. You will report to the Head of Department. Your new work location will be a high tech filling factory in Gentofte, where we produce GlucaGen. The production consists of the following processes: wash and sterilisation of equipment, formulation, sterile filtration, sterile filling in insulators, freeze drying and visual inspection Determine the department s quality objectives and ensure compliance Together with the Management team you will be responsible for ensuring that we comply with Novo Nordisk s quality system. As such, you participate in determining the quality objectives, and through planning and follow up on quality activity plans and conduction of quality management reviews you ensure that the standards are met. In this respect, you will join the support function, cooperate across the entire area and have close interaction with Quality Assurance. In this way, you provide sparring and consulting on quality and compliance inquires, as well as you interpret processes and come up with quality enhancing initiatives on the problems and improvements that you face in your everyday. In addition, you will drive and coordinate the quality work and secure continuous improvements of audits and inspections, as well as you coordinate and conduct training within GMP. You will be a member of the Management team and contribute to deciding on where to focus our efforts. You are a Pharmacist or an MSc in Civil Engineering or one of the natural sciences. You have gained solid experience with GMP and compliance from a pharmaceutical production e.g. as Production or QA Chemist. This has strengthened your ability to make even complex problem areas comprehensible for you and others and hereby ensuring overview and focus. It is an advantage if you have experience of leading others from a managerial or project management position. As a person you are known as a positive, structured and qualityoriented colleague capable of maintaining your humour and flexibility even in a busy and changing environment. You rely on your good cooperation skills and your passion for making a difference to ensure that cross functional tasks, involving many stakeholders, are solved. It is clear that you boost your level of energy through interaction with many various kinds of people during your work day. You can even demonstrate a series of examples on how you have engaged and motivated others to follow your example. The job requires that you are able to communicate in Danish and English. Head of Clinical Operations The Head will serve as the overall responsible for all Clinical Operations activities in close collaboration with the European Clinical Operations Director, and will furthermore serve as primary resource and point of communication for the client and project team for specific and complex projects. Direct Manager for 3 dedicated Nordic Clinical Operations Teams Experience with Clinical leadership, in terms of direct people Excellent organizational skills and team leading skills Leadership and direction to the clinical project teams, including specifications management and/or as Clinical Project Manager (preferably in a CRO) for time, quality and cost of deliverables Comprehensive clinical operational experience Cooperation with data management, biometrics and medical writing, medical A natural science degree or a pharmaceutical or medical degree is of services, pharmacovigilance and quality assurance advantage Participation in in house inspections and/or audits (internal and external) and The ability to think analytically and a talent for organizing are responding to audit/inspection reports Maintaining a flexible, can do approach to address issues innovatively and proactively Supporting Business Development in terms of drawing up of proposal texts and cost calculations in view of the conduct of national and international clinical trials in various indications required Ability to comprehend regulatory structures and procedures Ability to make oneself familiar with specific medical issues (e.g. study indications, symptoms, and methods for assessment of clinical parameters) Very good command of written and spoken English Ensure continued collaboration and alignment with the European Clinical Operations activities and colleagues. Head of Department, Your overall responsibility will be to develop the Medical Affairs Business Medical Affairs Business Support concept Support Develop and maintain processes relating to Global Medical Affairs, e.g. A Science degree combined with an MBA, or alternatively a development of a concept for the public appearance of Global Medical Affairs financial/commercial background combined with experience from life on congresses, symposia and other external meetings (i.e. materials, science industry and/or consultancy business, preferably related to information booths etc.). Medical Affairs. Act as system owner and facilitator for local systems supporting processes in Professional experience as process facilitator, i.e. LEAN coach and/or corporate medical affairs and global systems supporting processes in Global project manager. Medical Affairs, i.e. medical information and compliance systems. Experienced IT user with technical insight and ability to combine Guarantee systematic information exchange between CMA, Medical Directors organisational needs with technical solutions. and other stakeholders via annual Medical Director s meetings and/or regular Solid management experience. Tcons. Fluent in English written and oral. Act as member of global process forum for Medical Affairs & Clinical Development Centres. Finally, you will act as a key contact to Medical Affairs functions in affiliates. Result oriented; customer and goal oriented. Strong stakeholder management skills. Strong communication and interpersonal skills. Problem & conflict resolution oriented. Change driver. Net worker.
15 Head of Safety Operations and Risk Management The position as manager is a unique opportunity for working in the headquarter of ALK. The newly established team consists of 9 professionals (biologists, nurses, pharmacists, etc.). In this role you will spend approximately half your time on people management activities, e.g. coaching, motivating, goal setting, individual development plans, delegating tasks and responsibilities, manpower resource allocations etc. The rest will be spent on hands on safety surveillance work, e.g. safety surveillance process optimisation, case handling, review of aggregated safety reports; Liaising with internal and external departments and global offices/affiliates about safety procedures. The role also has a high level of involvement with PV compliance and legislation. Furthermore, the role may involve deputising for the Director of Pharmacovigilance when absent. You possess first rate people skills, with a leadership style characterized by empathy. You coach and motivate your team to high performance, and ensure that they reach their goals and manage deliverables timely and diligent. You see changes as opportunities and cope well when executing and communication change management. You are optimistic, energetic and proactive. You are a great communicator, structured, responsible and independent with a deep sense of ownership. Your analytical mind set and eye for detail make you able to prioritize tasks and work effectively under pressure when needed. A good sense of humour and a never failing "Yes we can attitude" will be a useful asset. Head of Section in Medicinal Chemistry We are seeking an experienced and motivated medicinal chemist to a senior position as Section Head in our Department of Medicinal Chemistry. You must have documented drug discovery experience and the ability to impact on and successfully lead a medicinal chemistry team. lead a medicinal chemistry section with 8 10 persons and be responsible for staff, working environment and scientific quality provide focus, motivation and optimal interactions within the section as well as project teams guide and secure progression of medicinal chemistry deliverables in the projects according to goals and milestones as a member of the management team in Chemical Research impact on strategic, technical, personnel and budgeting issues develop and maintain effective cross functional working relationships internally and externally You have a Ph.D in organic or medicinal chemistry with several years of good interdisciplinary team working skills with a goal oriented experience within the pharmaceutical industry with a proven track and flexible mind set record of identifying and progressing potential drug candidates. the desire and ability to communicate and collaborate the ability or experience to lead a successful medicinal chemistry team effectively across disciplines in LEO Pharma and with external the ability to inspire and support your team members with a genuine partners interest in their development an in depth knowledge of the drug discovery process and multipara metre optimisation, using a profound understanding of ADMET related issues Head of Section in Medicinal Chemistry We are seeking an experienced and motivated medicinal chemist to a senior position as Section Head in our Department of Medicinal Chemistry. You must have documented drug discovery experience and the ability to impact on and successfully lead a medicinal chemistry team. lead a medicinal chemistry section with 8 10 persons and be responsible for staff, working environment and scientific quality provide focus, motivation and optimal interactions within the section as well as project teams guide and secure progression of medicinal chemistry deliverables in the projects according to goals and milestones as a member of the management team in Chemical Research impact on strategic, technical, personnel and budgeting issues develop and maintain effective cross functional working relationships internally and externally You have a Ph.D in organic or medicinal chemistry with several years of experience within the pharmaceutical industry with a proven track record of identifying and progressing potential drug candidates. the ability or experience to lead a successful medicinal chemistry team the ability to inspire and support your team members with a genuine interest in their development an in depth knowledge of the drug discovery process and multipara metre optimisation, using a profound understanding of ADMET related issues good interdisciplinary team working skills with a goal oriented and flexible mind set the desire and ability to communicate and collaborate effectively across disciplines in LEO Pharma and with external partners
16 In vivo Pharmacologist The department is engaged in early to late phase drug discovery and the support of development research within psychiatry and neurology. Our objective is to identify novel drug targets that directly link into the neurobiological processes underlying disease pathology and to establish and mature drug discovery projects addressing these targets. To this end, we constantly evaluate and establish new models and assays that allow an advanced mechanistic understanding of the biological processes affected in patients and that offer translatability into clinical settings. Furthermore, we provide pre clinical support to compounds in development. Our team applies multi methodological approaches, including molecular biology, cell biology, electrophysiology, microdialysis and behaviour You will be actively involved in both early and late stage drug discovery projects and support these with in vivo derived pharmacology studies. You will independently identify, set up and validate suitable animal disease models as well as assay readouts required to advance the respective projects. Furthermore, you will be involved in team efforts of identifying and validating novel biological entry points leading to innovative drug targets for the treatment of CNS diseases. At the core of your job you will work with a multidisciplinary team to test compounds in vivo with the aim of identifying novel drugs. You are expected to be able to take part in inter disciplinary project groups and to secure the timely progression of research projects. A central aspect of the job involves establishment and maintenance of external research collaborations and participation in strategic discussions addressing our biology and disease focus. You will carry managerial responsibility for technical personnel and are expected to actively take part in laboratory work. A PhD in pharmacology, biology, or related biological sciences and post doc experience from either academia or industry. Strong experience in in vivo pre clinical CNS research with a focus on the assessment of rodent behaviour. Advanced scientific understanding of the molecular processes underlying synaptic transmission and the mechanisms of pharmacological interference therein. Ideally, hands on experience from drug discovery research. Experience with animal disease models addressing endophenotypes of psychiatric and/or neurological diseases. Fluent in oral and written English. Active external scientific network. Proactive, efficient, flexible and independent work style with a goal oriented and flexible mindset. Strong communicator and team player in multidisciplinary project teams. Industrial PhD Project The polyglutamine diseases are a class of inherited neurodegenerative disorders like Huntingtons disease and Machado Josephs disease which are characterized by an expansion of a polyglutamine tract within the respective protein. Data suggest that initial mechanisms for clearing polyq proteins through the ubiqutinproteasome pathway may be malfunctional and play an important role in the pathogensis of PolyQ diseases. Molecular chaperone proteins seem to be especially important proteins for regulating access of polyq protein to proteasomal degradation (for review see e.g. Arndt et al., Cell Mol Life Sci 2007; 64: ). The project is focused on investigating the early mechanisms involving chaperones proteins and E3 ligases and their importance for the UPS clearance of misfolded polyq proteins. The project is based at Lundbeck and the University of Copenhagen The project is divided between Dept. of Neurodegeneration (H. Lundbeck A/S) and Dept. of Biology (University of Copenhagen). The Dept. of Neurodegeneration is responsible for identifying and validating targets and is developing cell and animal based readout needed for either compounds or biologics to be developed into drug candidates. Techniques represented in the department range from molecular biology, biochemistry, cell based assays, in vivo electrophysiology to animal behaviour. The research activities at Dept. of Biology is primarily centered on intracellular protein degradation via the ubiquitin proteasome pathway You fulfil the formal criteria for obtaining an industrial PhD degree (described at oginnovationsprogrammer/hoejtuddannede ivirksomheder/erhvervsphd/hvad er en erhvervsphd/hvad kreves der) You hold a master degree in Biochemistry, Molecular Biology or related You have preferable knowledge on intracellular mechanisms central for regulating protein catabolic processes (e.g. regulation of ubiquitination, the proteasomal system and autophagy). You have preferable experience in using cell cultures to study clearance mechanisms of misfolded proteins. You should be interested in conducting in vivo studies as this is expected to be an important part of the late stage of the project You have excellent communication and presentation skills You are used to work in multi disciplinary environments Industrial PhD. The project is based at Lundbeck and the University of Copenhagen The project is divided between Dept. of Neurodegeneration (H. Lundbeck A/S) and Dept. of Biology (University of Copenhagen). The Dept. of Neurodegeneration is responsible for identifying and validating targets and is developing cell and animal based readout needed for either compounds or biologics to be developed into drug candidates. Techniques represented in the department range from molecular biology, biochemistry, cell based assays, in vivo electrophysiology to animal behaviour. The research activities at Dept. of Biology is primarily centered on intracellular protein degradation via the ubiquitin proteasome pathway You fulfil the formal criteria for obtaining an industrial PhD degree (described at oginnovationsprogrammer/hoejtuddannede ivirksomheder/erhvervsphd/hvad er en erhvervsphd/hvad kreves der) You hold a master degree in Biochemistry, Molecular Biology or related You have preferable knowledge on intracellular mechanisms central for regulating protein catabolic processes (e.g. regulation of ubiquitination, the proteasomal system and autophagy). You have preferable experience in using cell cultures to study clearance mechanisms of misfolded proteins. You should be interested in conducting in vivo studies as this is expected to be an important part of the late stage of the project You have excellent communication and presentation skills You are used to work in multi disciplinary environments
17 Infrastructure Management Specialist, Mobility The position Infrastructure Management Specialist, Mobility coordinates and manages operational and maintenance tasks for the mobility platform. This includes specification of operations requirements with the service provider and deployment of new services in accordance with the service catalog. The role also verifies service delivery of the service provider. Responsible for the operation of the sourced mobility platform service within the agreed SLAs and Quality parameters in Takeda CCO IS/IT Assist in integrating Apps into Takedas CCO IS/IT Infrastructure Platform Monitor and report performance of infrastructure components and services Deploy new services or changes in accordance with operations acceptance criteria Operate infrastructure components, provide 2nd level support, if required coordinate 3rd level support and according to ITIL processes and CCO IS/IT SOPs and guidelines Solve or escalate incidents and operating level breaches and prepare operating level reports Define infrastructure service requirements and operations acceptance criteria for service development projects and external providers Manage service providers operating the mobility platform infrastructure Computer Sciences graduate (BA, B.Sc., or similar qualification) Experience in the Pharmaceutical industry Deep knowledge of Mobility devices (Mobile Phones, Tablets) and solutions like BES, Good Technology Product Suite, App Stores (distribute Apps to mobile devices) etc. Ideally minimum 5 years experience in infrastructure Service Operations Experience in managing external service providers ITIL Foundation and familiar with all related processes Fluent English in writing and speaking Able to work in an international team and a global environment Independently drive solutions and focus on results International Business Developer For our client we are seeking an independent and Your main tasks will be to develop the commercial activities in Europe and in enterprising colleague with commercial flair to the rest of the world. You will maintain and develop extensive contacts with further develop the company s position as a world distributors of the company s brand products in the world. You will also leader in control sera for In Vitro Diagnostics. develop new business opportunities with international industry players in the IVD industry (identifying partners, establish partnerships, do needs analysis, lead and drive collaborative projects up to the final sale of the product). You will create results, by being operational and present in the market. The right candidate for this position has a higher education (financial or technical / scientific), good knowledge of the IVD industry with a specific focus on control serum or clinical chemistry, experience in international business, primarily B2B sale/relations. You must be fluent in both written and oral English and preferably also a further foreign language. You are a trustworthy relationship builder, who can work independently, structured and proactive to achieve the goals the company sets. You must be solution and result oriented, flexible, and have the ability to have many balls in the air simultaneously. You have no problems making new potential partners, and you express yourself clearly and precisely both orally and in writing. International Key Account Manager As an International Key Account Manager you will execute the sales in Denmark and throughout Europe. Reagent Partnership Division covers development, manufacturing and Retail Sales through distributors as well as OEM (B2B) sales to many of the worlds largest IVD companies. Dako s products are IVD approved clinical diagnostic products within the areas of Clinical immunochermistry market (specific proteins) and general antibody sales (e.g. to flow cytometry, ELISA etc.) As a team member of the EU Sales Team you will in collaboration with your colleagues be responsible for maintaining account information in SalesForce according to guidelines. You will follow up on strategic partnerships (preparation of contracts, opportunity seeking, client visits and customer reporting. Furthermore you will be responsible for OEM customer management, maintaining and developing necessary knowledge of the OEM market. Coordinating activities within Reagent Partnerships Driving contract negotiations within the framework of corporate legal guidelines as well as the continuous management of these Education or 5 years of experience within life science or other scientific/ technical background. High level of English, both written and verbal Good skills using IT systems As a person we expect that you have at least 3 5 years of sales and commercial experience. Also documented international experience in B2B sales will be required. You are a good communicator, and preferably extrovert and are happy working with different culture and people from all over the world and different scientific disciplines. A team focused working style but are self motivating and actionoriented A very flexible mindset with focus on getting the job done A structured, systematic and goal oriented mindset Experience with reporting and now the value International Marketing Manager Cheese Cultures Commercial Development are part of our Cultures & Enzymes Division and we are responsible for developing and executing the global marketing programs, shaping the future product lines and managing day to day activities in all stages of the product life cycle. You will be part of a strong and international team of 4 dedicated colleagues. You will have significant influence on the global marketing initiatives, which includes cooperation between Sales, Innovation and Marketing/Commercial Development. Ensure global business drive and product portfolio management for defined cheese segments incl. filling the innovation pipeline Secure relevant marketing intelligence activities, trends and improve our communication and tools for new product launches Support Sales for key negotiations including training and customer presentations and events Travel days a year You hold a B.Sc or M.Sc with a food technical background, preferably dairy/cheese You have several years of practical experience in combination with a commercial diploma or sales/marketing in the BtB segment for technical sales/application You are fluent in English and have strong presentation skills You are innovative able to identify new opportunities and make them happen You take pride in ensuring we all achieve and succeed as a team You can structure complex challenges and close cases in a timely manner
18 International PostDoc DRU is a research center providing drug candidates for changing diabetes and is an integrated research unit of Novo Nordisk. The project will focus on importance of insulin and IGF 1 in vascular function in collaboration with Mark T. Kearney, Professor of Cardiology, Head of Division of Cardiovascular and Diabetes Research, and Head of Division of Cardiovascular and Neuronal Remodelling. The candidate will become part of a laboratory located in a high impact center of excellence within diabetes and cardiovascular disease research and thus exposed to world class science and in addition serve as a liaison between the Division of Diabetes and Cardiovascular Disease, Leeds University and Insulin Biology, DRU, Novo Nordisk, Måløv, Denmark. You hold a PhD in molecular biology, biochemistry or related disciplines. Solid knowledge of cardiovascular functions, pathogenesis of diabetes and especially insulin effects on blood vessels is desirable. Experience with endothelial cell isolation, cell culture, and assays for measuring NO bioavailability like vasomotor functional assays using aortic rings are considered an advantage. We require very good communication skills in English. International Trial Managers Clinical Operation, Inflammation & GH is responsible for planning and implementation of clinical trial activities in accordance with the Clinical Development Plans within Inflammation and Growth Hormone. We cover projects within Rheumatoid Arthritis, Intestinal Bowel Disease, Systemic Lupus Erythematosus and Growth Hormone Deficiency. The scope of our activities is phase 1b to 3 clinical trials in collaboration with Contract Research Organisations and our Novo Nordisk affiliates. As International Trial Manager you will join a team of 40 highly skilled and ambitious colleagues working on global clinical development activities. By joining us you will get the opportunity to further develop your competencies within trial management in a global environment. You hold a university degree in medical, biological, pharmaceutical science or equivalent. You have a broad knowledge of clinical trials through 3 5 years of experience with execution of large scale clinical trials as well as a good understanding of project management. You have a quality mind set, communicate effectively and know how to prioritise between different tasks in a dynamic environment which requires a high degree of flexibility. You work independently while also being a dedicated team player. You have excellent cross cultural awareness and like to contribute to multi cultural project groups. Fluency in written and spoken English is essential. Junior Bioanalyst (Chemistry) The Junior Bioanalyst (Chemistry) will report to the Bioanalyst (Target Compound To be responsible for the prepartion of analytical standards The analysis of unknown peaks found in other analyses (under appropriate supervision) To be responsible for the maintenance of suitable stocking levels of lab comsumables To assist in set up and coordination of the activities in the labs Help in the preparation of manuscripts for publication in peer reviewed scientific journals To actively participate in networks and collaborations within the Center and the surrounding research community Handle and report experimental data in reports, lab notebooks and LIMS systems To carry out any other relevant duties that may be associated to the position, and may be required from time to time. A PhD (or equivalent) in Chemistry, Biochemistry or related discipline Or a Masters and a few years of practical experience from industry or academia Or a Bachelors Degree (or similar) and several years of practical experience from industry or academia Experience in working in high throughput analysis lab Experience in reporting in lab notebooks and/or LIMS systems Computer proficiency (Word, Excel, PowerPoint, LIMS) Excellent communication skills both oral and written Flexibility, enthusiasm, responsibility, team spirit and excellent collaboration skills Previous experience in working a research environment will be considered a distinct advantage Junior SDS Specialist Chr. Hansen i Hørsholm søger en nyuddannet Du er ansvarlig for udarbejdelse af sikkerhedsdatablade og anden nødvendig kollega til vores globale SDS team, der blandt dokumentation andet er ansvarlige for udarbejdelse af Du læser og fortolker kemikalielovgivning i Europa, USA, Canada, Australien sikkerhedsdatablade til de produkter Chr. Hansen m.fl producerer og markedsfører globalt. Vores Du klassificerer kemiske stoffer og produkter produkter er primært enzymer, naturlige farver og kulturer. Du er nyuddannet kemiingeniør, farmaceut eller har en anden relevant akademisk baggrund, alternativt er du en erfaren laborant Du er god til at kommunikere på dansk og engelsk både skriftligt og mundtligt Du har lyst til at arbejde med vurdering af kemiske stoffer og produkter, toksikologi, lovgivning og IT systemer, eksempelvis SAP, Lotus notes og WERCS Du er systematisk, struktureret og ansvarsbevidst overfor dine opgaver og omgivelser Som kollega har du en positiv og konstruktiv tilgang til mennesker og opgaver
19 Kemiker til QC Microbiology Her får du et tæt samarbejde med produktionsafdelinger, QC laboratorier og udvikling. Du får ansvar for mikrobiologiske analysemetoder og for at validere analysemetoder, kvalificere analyseudstyr og tilvejebringe den nødvendige dokumentation. fagligt ansvarlig for mikrobiologiske analyser, der udføres i forbindelse med kvalitetskontrol af produkter support til det daglige analysearbejde og godkendelser af mikrobiologiske analyser ansvar for procedurer, afvigelseshåndtering og trending vedrørende mikrobiologiske analyseresultater kvalificerings og valideringsaktiviteter optimering og kvalitetsforbedringer af analysemetoder og udstyr kontinuerlige forbedringer af arbejdsgange internt i teamet og på tværs af teams i bl.a. Quality Control Hørsholm, QA, Logistik og Produktion har en uddannelse som levnedsmiddelkandidat, ingeniør, farmaceut, biokemiker eller tilsvarende har viden om mikrobiologi og mikrobiologiske analyser har kendskab til GMP kommunikerer flydende, både mundtligt og skriftlig på dansk og engelsk er teamorienteret, arbejder struktureret, resultatorienteret og er parat til at tage ansvar forstår at arbejde målrettet, også når det gælder selvstændigt arbejde er positiv overfor forandringer Key Account Manager Med reference til Sales Manager for Abbott Diagnostics, bliver du en del af det danske team og en vigtig nøgleperson i indfrielsen af Abbotts ambitiøse vækststrategi. Markedsmæssigt dækker du et par af landets regioner og er sammen med dine kollegaer, ansvarlig for det langsigtede og komplekse relationssalg af diagnosticeringsudstyr til hospitalslaboratorier i Danmark. Du kan have bopæl alle steder i landet. Du får ansvaret for at styrke, udbygge og vedligeholde relationerne til de vigtigste beslutningstagere. Du indfrier kundernes efterspørgsel på information og ekspertise, ligesom du gennem kompetent faglig sparring med kunden øger kendskabet, udbredelsen og dermed salget af Abbotts udstyr. Du er på forkant med udviklingen i markedet, har forståelse for og kendskab til tender og udbudsprocesser samt evner at skabe merværdi for dine kunder og deres patienter. Du forstår at tænke strategisk, fremadrettet og planlægge dine salgsindsatser, men motiveres i marken hos kunderne og ved at en tålmodig og langsigtet salgsindsats belønnes Der kan være flere uddannelsesmæssige tilgange til denne stilling, men Du er en god kommunikator, stærk til at bygge relationer og ideelt er du Bioanalytiker eller Kemiker. Du har erfaring med komplekse evner at formidle dine budskaber på en troværdig måde. Selvom og langsigtede salgsprocesser og er, vant til at færdes på de danske dit job fordrer en høj grad af selvstændighed, er du en udpræget laboratorier. teamplayer. Kommerciel og international produktchef Til at drive et selvstændigt forretningsområde inden for kapitaludstyr til dyrlæger, dyreklinikker og dyrehospitaler søges der en selvstændig produktchef, som ønsker at bidrage fra strategi til eksekvering Du bliver en del af en produkt og marketingorganisation, som består af 16 personer, hvor du i samarbejde med to øvrige produktchefer får ansvaret for den strategisk udvikling af produkter inden for kapitaludstyr. Under denne kategori får du tildelt et selvstændigt budgetansvar for dit eget produktområde, hvor du får væsentlig indflydelse på den overordnede produktstrategi og efterfølgende udarbejdelse af handlingsplaner og struktur i eksekveringen. Dette indebærer bl.a. forhandling og etablering af kontakt til leverandører i samarbejde med strategisk indkøb, udarbejdelse af salgsmateriale i samarbejde med marketing, produkttræning af salgsorganisation samt teknisk support af kunder og kolleger. Du vurderer løbende de kommercielle muligheder inden for dit produktområde og deltager samtidig aktivt til udviklingen i den samlede produktorganisation. Du har solid erfaring som selvstændig produktchef i en mellemstor eller større international virksomhed, hvor du har formået at skabe kommercielle resultater. Om din erfaring stammer fra FMCG, tekniske veterinærprodukter eller lignende, er ikke afgørende. Blot du har en naturlig interesse for at tilegne dig den produktviden, som kræves.du er vant til at sikre eksekvering gennem et tæt samarbejde med øvrige produktchefer, indkøb og en international salgsorganisation. Vi forestiller os, at du har kombineret denne praktiske erfaring med en relevant kommerciel eller teknisk uddannelsesmæssig baggrund. Endelig behersker du engelsk flydende i skrift og tale. Du arbejder selvstændigt og tager et naturligt ejerskab for dit forretningsområde. Din motivationsfaktor er resultatskabelse, og du bidrager gerne med initiativer, konstruktive input og erfaringer, der kan skabe positiv fremdrift. Endelig er du struktureret, udadvendt, samarbejdsorienteret og besidder stærke kommunikative kompetencer. Konsulent Din hovedopgave bliver at rådgive medlemsvirksomheder indenfor slagtefjerkræ og ægsektoren om eksport og handelsmæssige forhold. Derudover skal du kunne arbejde politisk for at varetage medlemmernes interesser på den lange bane. Følger og påvirker dansk og europæisk lovgivning, handelsaftaler samt andre forhold af betydning for fjerkræsektorens rammebetingelser Yder rådgivning af høj kvalitet med fokus på vækst, konkurrenceevne og rammebetingelser Sikrer markedsåbning til nye markeder samt plejer og løser problemer på eksisterende eksportmarkeder Deltager i relevant internationalt arbejde på vegne af den danske fjerkræsektor, herunder i europæiske slagtefjerkræorganisation, Kommissionens rådgivende udvalg om prisprognoser m.m. Bidrager til tværgående projekter i L&F og har bred berøringsflade med L&F s øvrige medlemmer Udarbejder input til høringssvar til nationale myndigheder og EU systemet en relevant uddannelse på kandidatniveau minimum 5 års relevant erfaring fra det private/offentlige eller en branche/interesseorganisation og en vis tyngde med dig fra arbejdsmarkedet generelt gode formuleringsevner mundtligt/skriftligt på både dansk og engelsk du har både politisk og kommerciel forståelse du tager udgangspunkt i medlemmets forhold og kommunikerer forretningsorienteret du arbejder selvstændigt, prioriterer opgaverne og spiller selv bolden helt i mål du formår at begå dig med tæft og tydelighed og forstår at tilpasse din kommunikation til mennesker med forskellige baggrunde og kulturer
20 Konsulent til Markedsudvikling Din hovedopgave bliver at eksponere den danske er med til at udvikle afsætningsmuligheder på nye markeder fødevareeksport (både konventionelle og står for planlægningen og gennemførslen af eksportaktiviteter på tværs af økologiske fødevarer samt fødevareteknologi). Du brancher med særligt fokus på fødevarer og fødevareteknologi varetager projektledelsen for dine egne klæder mindre økologiske virksomheder på til eksport udviklingsprojekter, hvor du skal kunne dække indsamler og bearbejder markedsinformation alle aspekter lige fra at repræsentere os ved har projektledelse af eksportfremstød (med budgetansvar) officielle begivenheder til at stå for de helt udvikler nye aktiviteter med udgangspunkt i medlemmernes behov praktiske opgaver forbundet med projekterne. en relevant uddannelse på kandidatniveau nogle års erfaring og kommerciel og international erfaring fra fødevaresektoren gode formuleringsevner mundtligt/skriftligt på både dansk og engelsk (og evt. et tredje sprog) rutine i IT på brugerniveau du formår at tage et projekt hele vejen fra de store tanker til de praktiske opgaver du forstår at samarbejde på tværs af både fag og organisationer og trives med at have en stor kontaktflade du har evnen til at tænke kommercielt og har sans for forretningsudvikling du evner at udvikle og bevare gode langvarige relationer Vi tilbyder: Kvalitetsmedarbejder til frigivelse af lægemidler Som QP bliver du, sammen med de øvrige QP ere i afdelingen, ansvarlig for frigivelse af færdigvarer. Du kommer til at deltage i forskellige projekter og samarbejde på tværs af organisationen. frigive lægemidler til marked og klinik behandle afvigelses og ændringssager godkende produktionsmastere og certifikater Du skal desuden udarbejde og godkende skrevne retningslinjer og registreringsdokumentation samt forestå problemløsning i en travl hverdag. Da afdelingen har mange samarbejdsrelationer på tværs af organisationen, vil der være stor variation i dine arbejdsopgaver, og du vil komme til at deltage i tværgående projektarbejde. Vi forventer, at du er farmaceut eller akademiker med tilsvarende kvalifikationer, og at du har erfaring fra en lignende stilling eller har arbejdet i medicinalindustrien i flere år. Som person er du beslutningsdygtig og kan bevare overblikket i pressede situationer. Det falder dig naturligt at tage ansvar, og du er i stand til at optræde med den nødvendige autoritet. Du har flair for samarbejde og kommunikation og brænder for at være en god ambassadør for den virksomhed, du arbejder i. Desuden er du servicemindet og fleksibel, har lyst til at deltage i projekter og gør det med en positiv indstilling og godt humør. Laboratory Manager As Laboratory Manager you will work with a key focus on the managing part of the laboratory as well as being the link within the diagnostic and genetic testing strategies ensuring genetic integrity and health of Taconic animals.you will work in a team with other engaged colleagues and your primary area of responsibility will be to ensure the oversight of operational processes required to produce accurate and timely laboratory testing. Manage and coordinate operational testing strategies with global genetic and You hold an advanced degree in biomedical or veterinary science or health monitoring programs hold an equivalent degree combined with 3 5 years of relevant Participates in the identification, development and implementation of global technical/management experience testing strategies and methods in close collaboration with the laboratories and You are trained in microbiology with laboratory experience in the scientists culture, isolation and molecular identification of microbial species Manage and motivate the laboratory staff organized in the Molecular Analysis You have experience in laboratory management, animal health and Health Testing groups diagnostics and/or genetic analysis Ensure that all required resources are available proactively and maintained to You are experienced in a wide range of principles and methodology meet demands within the technical field and have knowledge of leading projects and Actively engage scientific community through presentations, literature review proven strong ability in leading cross functional internal teams and research collaborations to enhance Taconic products and services You are able to write reports, procedural instructions and/or policies. Ability to develop and execute publication and communication strategies with employees, customers and other stakeholders You are fluent in English (written and spoken), and a good communicator comfortable with presenting to small and large audiences You must be able to work effectively in an exciting busy, dynamic and global environment, able to adapt to different situations and find the best solution together with the team and with great confidence You must be a good team player, but also be able to work individually. Leder af kvalitetskontrol laboratorium i medicinalbranchen Som leder, skal du sikre optimale betingelser for effektiv afvikling af analysearbejdet og sikre at arbejdet foregår i henhold til GMP. Du får det fulde ansvar for afdelingen, herunder kvalitet, produktivitet, budget mv. Lede og udvikle de 2 teams via de 2 teamledere Fungere som eskaleringspunkt for at få løst vanskelige sager Sikre regulatorisk compliance i frigivelsesarbejdet Proaktivt tilpasse processer og standarder i henhold til regulatoriske ændringer Planlægge og sikre afvikling af analyseaktiviteter i tæt samspil med produktionen og andre stakeholders Forbedre og procesoptimere arbejdet Du har en relevant uddannelsesmæssig baggrund som f.eks. farmaceut, kemiker eller ingeniør. Solid erfaring fra kvalitetsstillinger i en GMP reguleret farmaceutisk virksomhed En stærk ledelsesmæssig og medarbejderudviklende profil Gerne kendskab til LEAN i praksis Du evner at arbejde selvstændigt og tage initiativer samtidig med, at du formår at lede gennem dine teamledere. Evnen til at håndtere en hektisk hverdag hvor du og dit team spiller en central rolle i mange forskellige aktiviteter Gode præsentations evner og en god portion humor Menneskelig pondus og stærk dømmekraft