Join our team of pioneers!

As a part of our team of more than 5.000 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.

Director* Protein & ADC Drug Substance

The (Associate) Director Protein & ADC Drug Substance will be part of the CMC project team leading external development and manufacturing activities of protein-based therapeutics and antibody drug conjugates (ADCs). He/she will provide scientific and technical input to all aspects of protein & ADC drug substance within CMC development programs with a special technical focus on protein purification and ADC bioconjugation. He/she 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 Substance will also provide strategic and scientific input to the assigned development programs being responsible for establishment and execution of the development strategy for protein & ADC drug substance. In addition, he/she will serve as a direct contact for CDMO partners related to the area of expertise.

Your main responsibilities are:

• Represent protein (mAb) and ADC drug substance expertise in assigned development programs with focus on protein purification and ADC bioconjugation
• 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 protein (mAb) and ADC drug substance 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 purification and bioconjugation for protein (mAb) and ADC modalities as well as related data quality through optimization of 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 (mAb) process development and manufacturing.
• Deep expertise in protein purification and ADC bioconjugation technologies
• 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 in generation of regulatory documents and regulatory filings for biologicals and/or ADCs (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 7804 (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

www.biontech.com