MSAT process engineer

Life Sciences

Process and Manufacturing

Master

Responsabilités

Support the introduction of new drug substance manufacturing processes by facilitating the technology transfer from development laboratories to large-scale GMP manufacturing facilities. This includes ensuring documentation readiness (e.g., conducting process fit-gap analyses, defining process control strategies, preparing media batch sheets and sampling plans) for clinical batch production, as well as providing support during process performance qualification to successfully implement new processes at manufacturing scale.
Identify and lead process improvement initiatives to increase process yield or robustness, and generate supportive data packages to enable implementation at manufacturing scale.
Provide ongoing support for existing commercial manufacturing processes through activities such as data trending and monitoring, developing scientific and technical study protocols and reports to support significant process changes, and contributing to investigations and process/product impact assessments for significant manufacturing deviations.

PhD or Master’s degree in Life Sciences with a minimum of 3 years (PhD) or 5 years (Master’s) relevant experience in process development or MSAT-like roles.
Fluent in oral and written English to effectively operate in an international environment.
Hands-on experience with mammalian cell culture processes at laboratory and/or manufacturing scale; familiarity with purification processes is considered an advantage.
Flexibility: Willingness to adapt to dynamic work demands, including occasional evening or weekend shifts, and supporting both small-scale lab studies and manufacturing-scale operations.
A team player who works effectively across multidisciplinary teams and fosters productive relationships.
Ability to adjust to shifting priorities in a fast-paced environment.
Strong interpersonal skills to connect with colleagues, facilitate discussions, and negotiate compromises with other departments or sites.
A precise, detail-oriented mindset with excellent analytical skills for identifying and addressing challenges.
Familiarity with statistical and data trending techniques; experience with tools like JMP, Statistica, Matlab, or Simca is a plus.
A solid understanding of current Good Manufacturing Practices (GMP); prior GMP experience is an asset.

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