Job Detail

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



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