about

Function: Biosafety Steward
Location: Huningue, France
Start: As soon as possible
Working hours: Full-time
Type of the contract: Permanent

Contact:
REBIAHI Célia
+41 78 211 63 71
celia.rebiahi@agap2.ch

your tasks

As Senior Consultant, you will be in charge of managing and coordinating all activities related to the identification and management of microbiological risks (bacteria, viruses, other agents) on a biopharmaceutical manufacturing site, including management of the respective microbial control strategy of the processes for the site, as well as management of the evaluation and improvement of the identification of microbiological risks and their mitigation.

Your tasks will include:

  • Developing and maintaining microbial risk assessments for the manufacturing processes of active substances (DS) for biological products on site (clinical and/or commercial phase)
  • Supporting the Production teams in root cause investigations and continuous improvement activities to reduce microbiological risks on site.
  • Participating in transfers and launches, liaising with technical development functions for new products and aligning with the microbial risk approach
  • Supporting the process validation team in definition, implementation, and closure of hold time studies of production products and intermediates to ensure the absence of microbiological risks
  • Promoting the application of appropriate behavior and c-GMP rules during manufacturing to avoid increased microbiological exposure of products during manufacturing

your profile

  • Sc. or Ph.D. in Biotechnology, Bioengineering, Pharmacy or equivalent, with minimum 8 years of experience in the field of manufacturing / science and production technology / technical development / quality
  • Familiarity with GMP requirements
  • Fluent English and French (read, written, spoken)
  • Master / Engineer degree in biotechnology, biochemistry or pharmaceutical industry

 

At agap2 you will work with a Technical Manager at your side who will follow, support and prepare you for next steps in your career. In addition, you can expect work in a friendly and dynamic team, extensive development opportunities and growing responsibilities.

 

Please send your application with an updated CV and a motivational letter to recruitment.basel@agap2.ch. Applications from Switzerland and EU only will be considered.