Scientist, Quality Control, Microbiology

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The Department

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 analysis on all batches produced for clinical and commercial use this including method validation. The chemical/ microbiological analyses on pharmaceutical water and TOC analysis on rinse samples from production. Further we are responsible for environmental monitoring (EM) in clean rooms (production rooms) and for re-/qualification.

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.

Within this broad working area, many different customers’ projects and with various biopharmaceuticals the QC department differs from traditional QC labs. The position requires an engaged, ambitious scientist with interest in particular Microbiology, analytic method validation, regulations, GMP and biopharmaceuticals production.

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

Tasks and Responsibilities

The position requires knowledge within microbiological analyses or the potential for achieve knowledge within this area. Coordination with external laboratories for microbiological analyses.

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. Gathering data for reports, writing deviations and constantly optimize procedure (SOP’s, TEQ’s ect.) ensure continuous compliance with cGMP with a LEAN mindset. Further, you can be involved in reporting data for environment monitoring of clean rooms and re-/qualification of production room.

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:

  • Basic understanding and knowledge of microbiology
  • Validation/qualification of microbiological methods and equipment
  • Experience in pharmaceutical water testing both chemical and microbiological analyses
  • Eventual knowledge on environmental monitoring and eventually qualification of clean rooms
  • Cleaning validation
  • Experience with writing protocol and reports.
  • General knowledge about regulatory requirement for microbiological analyses
  • Commercial GMP production and/or with production for late stage clinical trials
  • Production of biotechnological products and APIs
  • Regulatory inspections e.g. DMA, FDA and customer audits (internal and external audits).
  • 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 Sr. Manager, Susanne Vestergaard at +45 22942932.

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 17.2.2022, 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.
  • Forsker
  • København
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