*Scientist – QC – Environmental monitoring and Microbiology

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The Department

The QC department at AGC Biologics are responsible for supporting production of new biopharmaceuticals by controlling raw materials, performing analytical testing, environmental monitoring of production rooms, planning and executing stability programs and validating various analytical methods according to ICH guidelines from clinical phase I to phase III and commercial.

The department consists of: QC Bioassay, QC Chemistry, QC support, QC Planing and Systems and QC Microbiology. Where QC Microbiology consists of: QC Microbiology Laboratory and QC Environmental monitoring.

The vacant position is in QC Environmental monitoring (EM) department (consisting of 8 highly dedicated technicians, 3 skilled scientists and one manager). QC EM is responsible environmental monitoring (EM) in clean rooms, chemical/microbiological analyses on pharmaceutical water, and TOC analysis on rinse samples from production.

The department works in close collaboration with Manufacturing, QA, Up- and Downstream Development, 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

We are expanding the team as we are in progress of building a new factory at AGC. The new factory will be ready for qualifications of cleanrooms end 2023.

Tasks and Responsibilities

The position requires knowledge within environment monitoring of clean rooms and preferable microbiological analyses.

We are building a new facility and you will therefore be involved in qualification of cleanrooms. Besides that you will be responsible for clean room environment and the related 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. Gathering data for reports, writing deviations, changes requests and constantly optimize procedure (SOP’s, TEQ’s ect.) ensure continuous compliance with cGMP with a LEAN mindset. Further, you will be responsible for EM re-/qualification of production room.

Through internal and external audits, you can expect to build great expertise within these areas by interacting with our many different international customers.

Your profile

The ideal candidate holds a MSc or PhD degree in Pharmacy, Microbiology or other relevant field and has most likely knowledge in several of the following qualities:

· Solid knowledge on environmental monitoring and qualification of clean rooms in GMP production

· Experience with writing protocol and reports for EM, validation and SOPs.

· Basic understanding and knowledge of microbiology

· Validation/qualification of microbiological methods and equipment

· Regulatory inspections e.g. DMA, FDA and customer audits (internal and external audits).

· General knowledge about regulatory requirement for classified production areas as well for microbiological analyses

· Commercial GMP production and/or with production for late stage clinical trials

· Production of biotechnological products and APIs

· You like to share your knowledge and communicate openly and professionally both internally and with external customers

· You take responsibility for your personal assignment and thrive at reaching them in a timely manner

· You enjoy working in a high pace and be challenged in a busy business.

· You are a team player combined with the ability and desire to work independently

· Excellent communication, presentation and interpersonal skills

· Ability to apply organizational skills to systems and efficiency improvement

AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English.

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 regarding the position, please contact Manager, Jakob Knudsen at +45 27603029

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 6.6.2023, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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