Expert Upstream Process Development Proteins (Director)
Become a member of the BioNTech Family!
As a part of our team of more than 4.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
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.
The Expert Upstream Process Development Proteins will be part of the project team leading external development and manufacturing of protein based therapeutics. The Expert Upstream Process Development Proteins will support selection of Contract Development and Manufacturing Organizations (CDMO) and create project plans together with the CDMO. He/she will provide scientific and technical input to all aspects of cell line and upstream process development within CMC development programs and will be responsible for review and approval of external development documentation according to regulatory expectations. Based on the CMC development strategy, the Expert Upstream Process Development Proteins will also provide strategic and scientific input to the assigned development programs being responsible for establishment and execution of the cell line and upstream process development strategy. In addition, the Expert Upstream Process Development Proteins will serve as a direct contact for CDMO partners related to the area of expertise.
Your main responsibilities are:
- Support the selection of CDMOs and related CROs, develop detailed CMC project plans for the development and manufacturing of protein based therapeutics in close collaboration with the CDMOs/CROs
- Represent cell line and upstream process development expertise in assigned development programs
- Create, review, and approve (external) project documentation, including development reports, risk analysis, and qualification/validation reports according to regulatory guidelines
- Manage CMC timelines with respect to cell line and upstream process development activities, oversee budget and implement risk management, including proactive mitigation plans to help ensure effective program execution
- Drive timely and data-driven decision making, and contribute to strategic discussions within CMC as well as with other internal stakeholders and external partners
- Drive continuous improvement of cell line and upstream process development and data quality, through optimizing cell line and upstream technologies, automation, and digitalization
What you have to offer:
- Master’s degree or preferably PhD, in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
- Broad experience in cell line and upstream process technologies, preferably mammalian and microbial expression systems. Experience in additional protein expression systems is considered a plus
- Proven experience in CMC development of early- and late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages the drug development process.
- Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
- Leadership/management skills and assertiveness, capable of working in cross-functional CMC teams and with external stakeholders
- Excellent communication and negotiation skills as well as ability to communicate complex technical matters in a clear and concise way (e.g., to senior management)
Benefits for you.
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz and simply send us your application documents using our online form.
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 3310 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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