Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
AGC is looking for temporary (18 months) scientist within the Process Validation Department in Copenhagen, which requires process validation knowledge and a strong ability to drive interdepartmental collaboration.
The role of Process Validation Scientist offers opportunity to lead, coordinate and oversee process validation activities for late stage projects from initiation to completion. The Process Validation Scientist will be responsible for providing technical input to internal and external stakeholders as required throughout the process validation lifecycle. This includes activities required for process validation including the documentation (plans, protocols and reports); risk assessment (e.g. FMEA); mix and hold validation studies, monitoring and trending of data.
Key responsibilities:
- Plan, organize and execute process validation activities for drug substance manufacturing (e.g., mixing and hold validation, continued process verification).
- Generate process validation plans, protocols and reports in a timely manner and according to project requirements.
- Use scientific knowledge to analyze and interpret data, propose next steps and actions required. Take timely and appropriate action based on the data output.
- Interface with internal and external stakeholders and represent the department and the team effectively and professionally.
- Communicate and present findings at meetings as required.
- Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards.
The Department
The Process Validation department currently consists of 10 highly skilled scientists, 1 director, 3 managers and a student assistant. The department comprises Subject Matter Experts (SMEs) in management of PV activities, supporting studies (including risk assessments and mix and hold validation studies) as well as Continued Process Verification (CPV) monitoring. We have an open communication and strong support and flexibility within the department.
Your profile
Our ideal new colleague will have the following:
- Degree in biological science, engineering, or a related field (minimum M.Sc.).
- relevant experience in process validation within biopharmaceutical production and GMP is a plus
- Strong technical writing and presentation skills.
- Familiar with EMA, FDA, and ICH guidelines for process validation.
- Experience and knowledge in upstream and downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, is desirable.
- A fast learner with a positive mindset and drive.
- The company language is English, so excellent written and spoken English communication skills are required.
AGC Biologics Copenhagen
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. You will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team.
We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidate is found, the advert will close. We are therefore looking forward to receive your application today.
#JobsForUkraine
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 2.2.2023, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
Lignende jobs
-
Post Doc in Historical Geobiology using high-strat...
The Dahl Group at the Section for Geology is offering a Post Doc position for an excellent, ambitious, and highly motivated candidate with background in experimental sedimentary geochemistry and re..Få mere info- Forsker
- København K
-
Postdoc of Global Nutrition and Health
Få mere info- Forsker
- Frederiksberg
-
Adjunkt eller lektor til fysioterapeutuddannelsen
Vores ambition er at uddanne fysioterapeuter, som med ansvarlighed og stærk faglighed kan træde ud og repræsentere professionen på bedste vis i samfundet. Vil du være med til at skabe forpligtende .Få mere info- Forsker
- København N
-
PhD fellowship in plant proteins and data modellin...
Department of Food Science invites applicants for a PhD fellowship in Synergizing chemistry and data science to enhance plant-based food development.Start date is 1 February 2025 or as soon as .Få mere info- Forsker
- København
Statistik over udbudte jobs som forskere i København
Herunder ser du udviklingen i udbudte forsker i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal forskere i København.
Se flere statistikker her:
Statistik over udbudte forskere i København over tid
| Dato | Alle jobs som forskere |
|---|---|
| 26. november 2024 | 219 |
| 25. november 2024 | 227 |
| 24. november 2024 | 225 |
| 23. november 2024 | 220 |
| 22. november 2024 | 219 |
| 21. november 2024 | 225 |
| 20. november 2024 | 206 |
| 19. november 2024 | 200 |
| 18. november 2024 | 210 |
| 17. november 2024 | 215 |
| 16. november 2024 | 209 |
| 15. november 2024 | 238 |
| 14. november 2024 | 206 |
| 13. november 2024 | 223 |
| 12. november 2024 | 219 |
| 11. november 2024 | 222 |
| 10. november 2024 | 227 |
| 9. november 2024 | 231 |
| 8. november 2024 | 234 |
| 7. november 2024 | 236 |
| 6. november 2024 | 233 |
| 5. november 2024 | 226 |
| 4. november 2024 | 220 |
| 3. november 2024 | 230 |
| 2. november 2024 | 230 |
| 1. november 2024 | 249 |
| 31. oktober 2024 | 261 |
| 30. oktober 2024 | 262 |
| 29. oktober 2024 | 263 |
| 28. oktober 2024 | 266 |
| 27. oktober 2024 | 288 |
Værd at vide når du søger job som forsker i København
Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.
Bydele i København
København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:
Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.
Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.
Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.
Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.
Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.
Find ledige jobs i Valby
Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.
Mere information om København
Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer