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.
About the job
MSAT (Manufacturing, Science, Analytics and Technology) Vial & Cartridge Filling Excellence Frankfurt mission is to ensure successful maintenance and transfer-in of innovative drug products (monoclonal antibodies = mAB, microbial proteins) to FBC BLU (Frankfurt BioCampus, Biologics Launch Unit), and life cycle management (LCM) activities of marketed insulins products for FBC.
Our Galenics team, which is part of MSAT, is supporting the products transfer and LCM activities by process development studies and by the implementation and maintenance of Single Use Systems.
As Single Use Systems expert, you will be part of the Galenics team. You will be responsible for the evaluation (Extractables & Leachables, Filter Validation) of single use technology (e.g. filters, tubings, bags, assemblies) and development/establishment of new disposables used for the production of injectable drug products (mAB, microbial proteins and insulins) at FBC.
Main responsibilities:
- Extractables & Leachables (E&L) and Filter validation assessment
- Collect the necessary technical information
- Compile the available technical information and perform the assessment
- Coordinate the review and approval according to project timelines
- Plan, coordinate and perform Leachables and Filter Validation studies with external companies
- Work in close cooperation with the product team according to the project needs
- Act as primary process owner for filter validation and E&L incl. presentation of relevant topics during audits and share expertise at global level (e.g. in a "Community of Practice")
- Support regulatory dossier preparation and answers to Health Authority questions
- Support Change Control and Deviation process
- Support trouble shooting activities concerning Single Use Technology
- Creation of GMP documents (e.g. SOPs, PQ Plan)
- Apply and optimize Environmental Sustainability by Design principles into development of new products.
About you
Education and Professional experience
- Master in science (e.g. Pharmacy, Chemistry, Biotechnology)
- Professional experience in the pharmaceutical industry preferably in Quality Assurance or in Drug Product manufacturing
Technical skills & Competencies / Languages
- Precise way of working even under time pressure,
- Good organization skills,
- Very good knowledge in German and English (in writing & verbally), additional languages advantageous
- Profound MS-Office knowledge
- Ability to work in a regulated, international environment in diverse teams
- Good communication and presentation skills
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.
Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
