Associate Director Protein & ADC Drug Substance (Purification & Bioconjugation)

Associate Director Protein & ADC Drug Substance (Purification & Bioconjugation)

Mainz, Germany | full time | Job ID:9869

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). You 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. Also you 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, you 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 as DS lead and/or DS SME in assigned development programs with focus on protein purification and ADC bioconjugation
• 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 DS technical transfers between sites as DS process owner
• 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 Biotechnology, Bioprocess engineering, Biochemistry, 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) and ADC DS 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 concisely (e.g., to senior management)

It\'s our priority to support you:

• Your flexibility: flexible hours |vacation account
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germanylocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9869(please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

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