CMC Expert* Materials
- Work experience
- Project Management, Product Management
- Research, development, teaching
Become a member of the BioNTech Family!
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.
CMC Expert* Materials
- Lead the technical evaluation of potential sources of material, provide specifications for materials and perform quality assessment of materials within the global procurement process
- Define quality and critical quality attributes of new complex raw materials and excipients for the development programs in collaboration with our research and development teams
- Define global processes to ensure technical equivalence of materials and regulatory acceptance of all suppliers
- Drive continuous improvement of processes for assessment and procurement of raw materials and excipients
What you have to offer.
- Degree (MS/PhD) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with professional experience in an international, pharmaceutical environment
- Profound working experience in a leading quality function in a pharmaceutical environment (e.g. representative of quality function in project teams). Sound knowledge of GMP and ICH requirements for manufacturing and analytics for complex raw materials and excipients. Documented experience in relevant CMC regulatory affairs would be a plus
- Solid CMC development understanding of all stages of drug development; Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus.
- Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management; Experience defining and executing strategy is required
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, Margarita Hoffmann 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, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you