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About the role
As a QC Expert in the endotoxin laboratory within our FBC QC Microbiology team, you will take on scientific responsibility for method validations and analytical life cycle management—actively shaping the quality assurance of life-saving products. Ready to get started?
Become part of a global network that drives Sanofi's supply chain—seamlessly, purposefully, and at scale. In production and manufacturing, you will help find new ways to ensure life-changing treatments reach people worldwide faster. In our endotoxin laboratory at the Frankfurt site, you will work in a scientifically demanding, GxP-regulated environment and serve as the central expert for the entire analytical method life cycle—from initial validation to the continuous optimization of testing methods.
About Sanofi:
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our deep understanding of the immune system—and our innovative pipeline—enables us to develop medicines and vaccines that treat and protect millions of people worldwide. Together, we explore the wonders of science to improve people's lives.
Key Responsibilities:
- You will plan and coordinate method development projects, method verifications and validations, as well as hold-time studies in the endotoxin area—from scientific conception to report generation in English.
- You will assume technical leadership of studies, evaluate results, and derive appropriate measures within the framework of the method life cycle.
- You will process and evaluate deviations, out-of-specification (OOS) results, and change controls, act as an investigation lead, and be responsible for the timely implementation of corrective and preventive actions (CAPAs).
- You will create, revise, and approve documents (Standard Operating Procedures, method documents, reports) in German and English and ensure GxP-compliant documentation of all activities.
- You will provide technical guidance and support to QC analysts, coordinate laboratory workflows, and oversee the onboarding and training of new team members.
- You will prepare for internal and external inspections, actively present as a subject matter expert during regulatory inspections, and drive the continuous improvement process in the laboratory.
- You will take on tasks in the area of occupational safety and environmental protection (HSE), including the review of risk assessments, and participate in national and international projects.
About you
Experience:
- Experience in testing for bacterial endotoxins (e.g., LAL tests, rFC assay) as well as in method development and validation/verification;
- Sound knowledge of relevant requirements (guidelines, pharmacopoeias such as the European Pharmacopoeia / Ph. Eur. and USP);
- Experience with the management of deviations, out-of-specification results, and corrective actions, as well as internal and external inspections, is an advantage.
Soft Skills / Technical Skills:
- Strong analytical and conceptual mindset, structured and independent working style;
- Strong communication skills and a passion for technical leadership and teamwork;
- High quality awareness and regulatory understanding.
Education:
- Completed degree in chemistry, biochemistry, biology, pharmacy, or a comparable field—alternatively, a completed vocational training with further qualification (e.g., technician) and relevant professional experience in a GxP-regulated environment.
Languages:
- Fluent German skills;
- Good English skills for international reports and projects.
Why should you choose us?
- Discover the wonders of science with an innovative team to improve people's health.
- Find diverse opportunities in an international work environment to develop your talent professionally and personally and to continuously advance your career through internal moves and role expansions. Individual and structured onboarding is a matter of course and begins even before your first day.
- An attractive, market-oriented compensation and benefits package, including a company pension scheme, rewards your experience and contribution.
- We care about you and your family with a wide range of health and social benefits such as high-quality healthcare, many prevention programs, free vaccinations, and protection in case of long-term illness. Outstanding is our 14-week paid family leave after the birth of a child for both parents, as well as various other support options for childcare and the care of relatives.
- Start your career at an attractive location in the heart of Germany and experience our modern work environments. For your commute, you will be supported by an individually usable monthly mobility budget.
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!
The salary range for this position is :€80 724,00 - €107 620
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.