The individual in this role is responsible for managing the Chemistry and Microbiology Testing Support group within Analytical Excellence and ensures that the life-cycle management of analytical methods is implemented and aligned with applicable Sanofi and regulatory requirements. He/she is responsible for continuous improvement activities, for enabling innovation, and for introduction of new technologies into QC Chemistry and Microbiology laboratories.
The incumbent is expected to lead/support complex investigations related to QC methods in QC Chemistry and Microbiology labs, and act as key liaison for technical interactions and assessment/management of changes with internal stakeholders, health authorities, local and global auditors.
- Provide day-to-day supervision of the Pharmaceutical Testing Support group in Analytical Excellence. Ensure resources are planned and utilized effectively
- Enable Life-cycle management of analytical test methods in Pharmaceutical Testing Support group. Ensure QC test methods are assessed according to the pre-defined schedule and all gaps identified are addressed in a timely manner
- Lead the continuous improvement activities of QC test methods in Chemistry and Microbiology laboratories. Coordinate and oversee technical transfers and enable implementation of new technologies
- Lead complex OOS/OOT investigations and advanced troubleshooting
- Work closely with MTech, R&D, Quality Operation, Validation System, Regulatory affairs and Health Authorities, for investigations, technical questions and test-related changes
- Act as an SME for Pharmaceutical Testing Support group and as a key contact for Regulatory Inspections
- Support new processes/new vaccine development in method validation
- The incumbent will make decisions on the life-cycle management of analytical methods
- Responsible for interpretation of cGMPs and industry guidance to achieve required compliance levels
Education and experience
- PhD in Chemistry, Microbiology or a related field, such as Biochemistry, Biomedical Sciences or Molecular Biology, with 5 years previous relevant experience. Alternatively, a Master of Science degree and 8 or more years of previous experience within a vaccine or biologics manufacturing industry
- Excellent knowledge of analytical methods, including chemistry, microbiology and virology, and life-cycle management of methods.
- Extensive experience with continuous improvement methodologies with demonstrated performance and project management.
Key technical competencies and soft skills
- Strong GMP background including working knowledge of GLP/GMP
- Sound knowledge of pharmacopeia testing
- Strong supervisory, and both written and oral communications skills
- Strong analytical and balanced decision making skills
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.