Manager* AS&T Fill & Finish
- 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 Fill & Finish Operations
Your main responsibilities will be:
- Directing and providing analytical and technical knowledge in the day-to-day and strategic function of AS&T including method transfer and compendial method verification
- Developing, qualifying, and validating analytical methods
- Providing required infrastructure, guidance, and strategic direction to the team
- Introducing new state-of-the art analytical technologies
- Providing technical expertise in F&F testing including analytical method technology transfer, analytical method development, and sample testing at external labs
- Functioning as interface with external labs, Contract Manufacturing Organization (CMOs) as well as internal development units
- Writing, reviewing and approving qualification, validation protocols, and F&F analytical protocols and reports for both internal and external use
- Communicating on relevant topics including method transfer, material request, and documentation
What you have to offer.
- University degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology)
- Several years of practical experience in Sterile Manufacturing and in Biotech or pharmaceutical QC Laboratory; ideally including analytical method development and optimization
- Deep expertise in F&F process steps including QC Release testing (Container Closure, etc.) and equipment associated with testing of biopharmaceutical products
- High team spirit and excellent collaborating skills; effective stakeholder management skills, both in cross-functional internal and external matrix team environment; ideally experience with working with CMOs
- Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, Good Manufacturing Practice, as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia)
- Excellent technical writing skills
- Conscientiousness and detail-orientation
- Creativity and the ability to develop a flexible approach to changing conditions
- Refined colloquial and correspondence skills in both German and English; presentation skills adaptable to all levels of internal and external stakeholders
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