Analytical Lead and Expert Preclincal Bioassays - all genders -

About the job

As Analytical Lead, you will serve as a member of Technical Product Team(s) for a product or a portfolio of products and will be responsible for overseeing, leading and coordinating execution of analytical activities for late stage and commercial biologics.

Additionally, you will coordinate and follow-up on Insulin-bioassays running at external suppliers.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Expert for Analytical Life Cycle Management and Method Transfer/Validation within our MSAT, will be to support the launch of new products.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Serve as the primary contact for assigned product / product family for the MSAT Global Analytical function. Represent Global MSAT Analytical in CMC/technical product teams, maintain thorough knowledge of assigned product(s), ensures execution of analytical work within MSAT and externally to support characterization, comparability, investigations, and process development.
• Coordinate and follow-up on experiments at external suppliers for bioassays
• Responsible for development of analytical control strategy specification setting, risk assessment and comparability activities related to new product introduction, process changes, tech transfer, etc. as appropriate.
• Lead / oversee ALCM activities including automation, internally and externally/outsourced as applicable, including assay development, transfer, SME support for assigned product(s).
• Provide input to regulatory dossiers, provide responses to questions from authorities

About you

• Experience: 5+ years’ experience in development and manufacturing of biopharmaceutical products, preferably in analytical sciences
• Soft and technical skills:  
  • Experience with analytical transfers, bioassays, automation, development, regulatory requirements, dossier writing, cGMP knowledge, HA regulations and interactions
  • Actively making decisions to drive related decision-making processes
  • Enjoying collaboration in interdisciplinary teams and being open and winning with people
  • Self-employed, organizational and purposeful
  • Ability to present even complex contexts accurately and comprehensibly
  • Anticipate risk and bring about proactive, effective and innovative solutions
• Education: PhD or Master in Science (University), Chemistry, Biochemistry, Biotechnology, Chemical engineering or Pharmacist
• Languages: Fluency in English and German, verbally as well as in writing

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
• We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.