Senior Director* CMC Portfolio Lead 2
- Manager First Level
- Research, development, teaching
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.
Senior Director* CMC Portfolio Lead
Your main responsibilities are:
- Lead the team of CMC Experts for the defined portfolio and provide technical and strategic oversight of the projects
- Ensure harmonization of CMC technical and regulatory development strategies for project and adaptation according to internal and external discussion with eg competent authorities
- Manage CMC timelines and budget; bring focus to risk management activities and implement processes to identify risks, maintain risk registry and proactively execute mitigation plans to help ensure effective program execution
- Drive timely and data-driven decision making, and facilitate strategic discussions within CMC and with external partners to inform product development
- Drive continuous improvement of process and data quality, through streamlining and optimizing processes as well as automation and digitalization
What you have to offer.
- An Advanced Degree (MS/PhD) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with several years professional experience in an international, pharmaceutical environment
- Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing). Documented experience in CMC regulatory affairs would be a plus
- In depth CMC development knowledge in either early or late stage projects with sound understanding of all stages of drug development; Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus
- Leadership, seniority and assertiveness, capable of leading CMC teams
- 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, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6325 (please indicate for inquiries)
We look forward to your application!
*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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