Job Beskrivelse Primære opgaver Uddannelse og professionel erfaring Personlige kompetencer Akademiker til product care og produktions support

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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.