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

 

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

 

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)