About the job

As Single Use Systems expert within our Galenics team, you’ll 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) filled at the above mentioned Sites. Ready to get started?

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 SFB&O (Site Frankfurt Biologics & Oncology), and life cycle management (LCM) activities of marketed insulins products for ICF (Insulin Campus Frankfurt).

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.

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:

• 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 E&L 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 on a 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)

About you

• Experience :

• Professional experience in the pharmaceutical industry preferably in Quality Assurance or in Drug Product manufacturing

• Soft and technical skills :

• Precise way of working even under pressure

• Good organization skills

• Ability to work in a regulated, international environment in diverse teams

• Profound MS-Office knowledge

• Good communication and presentation skills

• Education :

• Master in science (e.g. Pharmacy, Chemistry, Biotechnology)

• Languages :

• Very good knowledge in German and English (in writing & verbally), additional languages advantageous

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.

• Start your career at an attractive location in the center of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

Pursue Progress . Discover Extraordinary .

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !