Process Engineer/Analytical Dev Sp II

Sanofi

Geel, Belgium

About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Process Engineer in our Manufacturing Science & Analytical Technology (MSAT) Cell Culture team, you’ll focus on the upstream part of the biopharmaceutical manufacturing process. Leveraging strong scientific and technical knowledge, you will actively contribute to the technology transfer and commercial production of a new process at an external manufacturing partner (CMO) abroad. This position will involve frequent international travel and close collaboration with both internal stakeholders and the external partner to ensure a successful transfer and robust commercial manufacturing.

Main responsibilities

New Product Introductions: Facilitate the technology transfer of biological drug substance manufacturing processes from development laboratories to large-scale GMP manufacturing facilities. This includes ensuring documentation readiness for clinical batch production, as well as providing support during process performance qualification to successfully implement new processes at manufacturing scale;
Process Improvements: Identify and lead process improvement initiatives to increase process yield or robustness, and generate supportive data packages to enable implementation at manufacturing scale;
Commercial Production Support: Provide ongoing support for 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.

About you

Education: PhD or Master’s degree in Life Sciences (or equivalent through experience);
Soft and technical skills:
- 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 to support 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, or Simca is a plus;
- A solid understanding of current Good Manufacturing Practices (GMP); prior GMP experience is an asset.
Languages: Fluent in oral and written English to effectively operate in an international environment.