Associate Director* AS&T - CMO Oversight
- Senior, very experienced
- 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.
Associate Director* AS&T CMO Oversight
Your main responsibilities will be:
- Supporting CMOs during whole onboarding process regarding analytical/microbial test transfer and test set up, stability studies and sampling plans
- Conducting analytical investigations (OOS, complaints, deviations) and problem solving activities during technology transfer and routine production in internal and external laboratories and at CMOs in case of analytical/microbial test deviations
- Facilitating analytical technology transfer projects, writing of transfer documents like analytical GAP analysis, transfer strategy, method transfer plans and reports
- Overseeing the creation/revision and approval of AS&T-owned Standard Operating Procedures (SOPs), work instructions, technical documentation package and other supporting documents
- Supporting the evaluation and implementation of new technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders
- Providing support for troubleshooting and continuous improvement in the laboratory
What you have to offer.
a) University degree in pharmaceutical or Science/Chemistry (or equivalent),
plus practical experience on a manufacturing site or with external partners (CMOs), as well as with managing CMO quality and analytical method transfer
b) Advanced degree in life science or healthcare (or equivalent), plus practical experience of quality compliance governance, and good understanding of quality compliance management obligations (incl. statutory obligations), requirements, requirements and dynamics
- Several years of working experience and good knowledge of the QA/QC release process
- Profound knowledge of relevant US and EU, EMA, FDA regulatory standards as well as Good Manufacturing Practice; especially good understanding of quality compliance management obligations (incl. statutory obligations), requirements, requirements and dynamics
- Creativity and the ability to develop a flexible approach to changing conditions
- High conscientiousness and detail-orientation
- High team spirit, excellent collaborating skills, and effective stakeholder management skills
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!
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