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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.

Associate Director* Protein & ADC Drug Product

The (Associate) Director Protein & ADC Drug Product will be part of the CMC project team leading external development and manufacturing activities of protein-based therapeutics and antibody drug conjugates (ADCs). The (Associate) Director Protein & ADC Drug Product 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 formulation and drug product 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 (Associate) Director Protein & ADC Drug Product will also provide strategic and scientific input to the assigned development programs being responsible for establishment and execution of the formulation and drug product development strategy. In addition, the/she will serve as a direct contact for CDMO partners related to the area of expertise.

Your main responsibilities are:

• Represent formulation and drug product expertise in assigned early and late stage development programs
• Establish close technical collaboration with internal stakeholders and external partners
• Create, review, and approve (external) project documentation, including development reports, risk analysis, and qualification/validation reports according to regulatory guidelines
• Support GMP DP manufacturing by scientific and technical input including troubleshooting and assessment of process changes.
• Support clinical trial management and clinical operations with review of IMP questionnaires, pharmacy manuals and organization of clinical in-use studies.
• Manage CMC timelines with respect to formulation and drug product 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 formulation and drug product development as well as data quality, through optimizing 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 protein formulation as well as drug product delivery and process technologies. Experience with high-concentration formulations, ADCs and clinical in-use studies is considered a plus.
• Proven experience in CMC development of early- and/or late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages of the drug development process.
• Experience with generation of regulatory documents and 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:

• Flexible Working Time
• Mobile Office
• Work from EU Countries (up to 20 days per year)
• Company Pension Scheme
• Childcare
• Jobticket
• Company Bike
• Leave Account
• Fitness Courses
  

... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz Goldgrube 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 7803 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not tolerate discrimination, favoritism, or harassment based on 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!

BioNTech - As unique as you

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