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
Experience
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
Independent, organizational and purposeful
Ability to present and 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 German and English, verbally as well as in writing
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.
