Associate Director Drug Substance Lead

Vor 3 Tagen

Munich, Bayern, Deutschland Discover International Vollzeit
Job Title:

Associate Director Drug Substance

Job Summary:

The Associate Director Drug Substance is responsible for overseeing the technology transfer of drug substance manufacturing processes, particularly Antibody-Drug Conjugates, for both investigational and commercial drugs. This role involves managing the Site Launch Team and ensuring smooth transitions from development to routine manufacture, both internally and externally.

Key Responsibilities:
  1. Lead and coordinate activities for site launches, overseeing teams across internal and external manufacturing sites as well as development projects.
  2. Act as the main point of contact between internal teams and external sites, ensuring seamless communication and collaboration.
  3. Review and manage technical documents related to manufacturing processes, technology transfers, site transfers, and PPQ.
  4. Scout and recommend CDMOs for clinical trials and launch site selection based on project needs.
  5. Communicate and implement manufacturing plans, ensuring alignment with cross-functional CMC strategies.
  6. Ensure key outcomes from meetings are effectively communicated to stakeholders and relevant functional areas.
  7. Provide technical recommendations for future manufacturing site selections and improvements.
  8. Gather and analyze data to drive performance improvements at drug substance manufacturing sites.
  9. Manage data review, analysis, and transfer, serving as a liaison between Tech Strategy and the manufacturing site.
  10. Recommend risk mitigation strategies, including CAPAs, and offer inspection support as needed.
  11. Participate in CMC working group meetings, providing timely updates on technology transfers and site activities.
  12. Assist with compiling and reviewing CMC sections of regulatory submissions and responses to regulatory inquiries.
Requirements:
  • Relevant degree within life science
  • Minimum of 5 years in the pharmaceutical/biotechnology industry
  • Experience in ADC & Bioconjugation
  • Excellent verbal and written communication skills in English
  • Experience leading global projects and cross-functional teams
  • Ability to contribute to operational planning and manage key functional processes

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