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The overall QC department at AGC Biologics consists of QC Bioassay, QC Chemistry, QC Microbiology, QC Raw Materials and QC Stability.
The vacant position is for a scientist in QC Microbiology department (consisting of 12 highly dedicated technicians, 6 skilled scientists, a team lead and a manager). QC Microbiology is responsible for the microbiological analyses (bacteria, fungi, virus and mycoplasma) on all batches produced for clinical and commercial use. We are also responsible for the chemical/microbiological analyses on pharmaceutical water and TOC analysis on rinse samples from production. Further, environmental monitoring (EM) in clean rooms (production rooms) and re-/qualification of the rooms is performed by QC Microbiology.
The QC Microbiology department works in close collaboration with Manufacturing, Quality Assurance, Up- and Downstream Development, Other QC departments, Analytical Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers.
Your tasks and responsibilities:
You will be responsible QC Microbiology scientist for the microbiological analyses in the department, where evaluation of results and generation of project related GMP documentation will be a natural part of your daily work.
Coordinate with external laboratories for bulk harvest analyses including virus- and mycoplasma analyses.
Gathering data for reports, writing deviations and constantly optimize procedure (SOP’s, TEQ’s ect.) ensure continuous compliance with GMP with a LEAN mindset.
Further, you will be involved in qualification of equipment for QC microbiology.
Your profile:
The ideal candidate holds a MSc or PhD degree in Microbiology or other relevant field and have some of the following qualifications:
- Basic understanding and knowledge of microbiology.
- Experience with virus safety testing.
- Validation/qualification of microbiological methods and equipment.
- Cleaning validation including TOC validation.
- GMP and biopharmaceuticals production.
- Enjoy working in close collaboration with your colleagues.
- You are structured and responsible with respect for deadlines and quality.
- Like to share your knowledge and communicate openly and professionally both internally and with external customers.
- You enjoy working in a high pace and be challenged in a busy business.
- Excellent communication, presentation and interpersonal skills.
This job position also applies for newly graduates.
AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English.
For further information regarding the position, please contact Sr. Manager, Susanne Vestergaard at +45 22942932
AGC offers
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. Exciting and challenging assignments will keep coming your way, but 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, in accordance with our slogan - Right. On Time.
We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receive your application today!
For further information, please contact Susanne Vestergaard at [email protected]
For agencies, please contact our Talent Acquisition team at [email protected]
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 14.4.2022, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
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