Associate Director Protein & ADC Drug Substance (Purification & Bioconjugation) (m/f/d)

Your Profile:

• 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)

Your Tasks:

• 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

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