Biotech Process Engineer

LausanneTemporaireChimie, Pharma, Biotechnologie2019-03-13Master / Université
We are recruiting a Biotech Process Engineer for a temporary contract in a biopharmaceutical industry

Biotech Process Engineer

Your Responsibilities

  • Coordinate outsourced activities, ensuring CMOs accountability for the quality of their deliverables
  • Review external documentation (protocols, reports, quotations, batch reports...)
  • Plan and coordinate team meetings with sub-contractors and follow-on with actions
  • Contribute to the preparation of CMC and regulatory documentation for biotech APIs and drug product
  • Ensure timely delivery of products (DS/DP)
  • Ensure external activities adhere to GMP, regulatory guidelines, standard processes and SOPs, where applicable
  • Propose optimized / agile routes for process improvement
  • Assist with requests from Health Authorities
  • Keep aware of current scientific and regulatory knowledge

Your Profile

  • Engineer or MSc. in biotechnology / biochemistry or related field
  • Minimum of 5 years' experience in the pharmaceutical industry or CMO
  • Strong knowledge in biotech product development and manufacturing (antibodies, ADCs,...)
  • Expertise in drug product fill & finish is required
  • Knowledge in small molecules formulation is a plus.
  • Good experience of sub-contracting environment and ability to foster strong partnerships
  • Up to date knowledge of CMC regulatory requirements
  • Good communication skills and ability to build positive relationships with internal / external entities
  • Fluent in French and English

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -032019-295192