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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
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

À propos de Spring Professional
Booster votre carrière, décrocher un emploi qui vous motive ou trouver une nouvelle opportunité pour vous épanouir dans votre vie professionnelle. Autant d'objectifs auxquels nous croyons et pour lesquels nous vous conseillons jour après jour. Spring Professional est une entreprise de The Adecco Group, spécialisée dans le placement fixe et temporaire de professionnels qualifiés.

Découvrez ce que nous pouvons faire pour vous. Postulez à ce poste ou à l'un des plus de 500 autres postes sur

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Merci de préciser la référence JN -032019-295192.

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