(Senior) CMC Expert* Asia
- 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.
(Senior) CMC Expert* Asia
- Develop detailed CMC project plans related to our Asian cooperations in collaboration with technical leads and expertise areas (e.g. Process/Analytical Development, Quality, Regulatory, Supply Chain, Operations, Commercial)
- Ensure alignment with global strategic and operational functions within the organization
- Lead the scientific/technical assessment of development programs related to all CMC aspects
- Manage CMC timelines and budget as well as risk management, incl. implementation of processes to identify risks, maintain risk registry and proactively execute mitigation plans
- Drive timely and data-driven decision making, and facilitate strategic discussions within CMC and with external partners as well as continuous improvement of process and data quality, through streamlining and optimizing processes, automation, and digitalization
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 function in a pharmaceutical environment, a good understanding of pharmaceutical regulations in Asia is requiered. Sound knowledge of GMP and ICH requirements for manufacturing and analytics. 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
- Asian language skills (written and spoken) would be a plus
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 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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