Manager* AS&T Stability study Program
- Work experience
- Production, manufacturing
- Quality Management, Quality Assurance
Become a member of the BioNTech Family!
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Manager AS&T Stability Program
Your main responsibilities will be:
- Coordinating and setting-up commercial stability studies at Contract Manufacturing Organization (CMOs) and external labs
- Writing or reviewing stability reports and protocols and approval of stability relevant regulatory documents for Health Authorities
- Overseeing QC-stability-related compliance activates, including investigation closure of any Out-of-Specification/Out-of-Specification/Atypical Results/Corrective and Preventive Action events
- Building and maintaining a working knowledge of current requirements of worldwide regulatory bodies for stability testing of pharmaceutical products
- Being responsible for analytical / stability storage projects
What you have to offer.
- University degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology)
- Several years of practical experience within QC (method development, method validation, stability testing), as well as in in Sterile Manufacturing
- Several years of work experience in a Good Manufacturing Practice (GMP) laboratory role in a biotech or pharmaceutical QC laboratory
- Thorough knowledge of Fill and Finish process steps including QC Release testing (Container Closure, etc.) and equipment associated with testing of biopharmaceutical products
- Proven track record with regulatory inspections (EMA/FDA or other)
- Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, and GMP as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia)
- High conscientiousness and detail-orientation
- High team spirit, excellent collaborating skills, and effective stakeholder management skills
- Very good communication skills, fluency in German and English
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you