Director* CMC Cell & Gene
- Work experience
- 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.
Director* CMC Cell & Gene
Your main responsibilities are:
- Collaborate with technical leads and expertise areas (Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Commercial) to develop detailed CMC project plans required to successfully progress an asset from pre-clinical through clinical phases specifically in the field of cell based therapeutics (ATMPs)
- Lead the scientific assessment of development programs related to all CMC aspects as the CMC project lead
- 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
- Promote 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.
- Advanced degree (Ms/PhD) in Science (Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology) with at least 5 years of relevant industry experience in biologics development, preferably in the field of cell based therapeutics/ATMPs.
- 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
- Prior experience in project leadership or people management paired with the ability to engage cross-functional 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
- A regulatory background and/or experience in writing of regulatory documents (IND/IMPDs) for clinical stage or marketed products 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, 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 6326 (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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