Chief Manufacturing Specialist: ADC

Vor 2 Tagen

Munich, Bayern, Deutschland Discover International Vollzeit

Job Title:

Associate Director Drug Substance (ADC & Bioconjugation)

 

About the Role

The successful candidate will oversee the technology transfer of drug substance manufacturing processes, particularly Antibody-Drug Conjugates and Bioconjugations, 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.

 

Main Responsibilities
  • Lead and coordinate activities for site launches, overseeing teams across internal and external manufacturing sites as well as development projects.
  • Act as the main point of contact between internal teams and external sites, ensuring seamless communication and collaboration.
  • Review and manage technical documents related to manufacturing processes, technology transfers, site transfers, and PPQ.
  • Scout and recommend CDMOs for clinical trials and launch site selection based on project needs.
  • Communicate and implement manufacturing plans, ensuring alignment with cross-functional CMC strategies.
  • Ensure key outcomes from meetings are effectively communicated to stakeholders and relevant functional areas.
  • Provide technical recommendations for future manufacturing site selections and improvements.
  • Gather and analyze data to drive performance improvements at drug substance manufacturing sites.
  • Manage data review, analysis, and transfer, serving as a liaison between Tech Strategy and the manufacturing site.
  • Recommend risk mitigation strategies, including CAPAs, and offer inspection support as needed.
  • Participate in CMC working group meetings, providing timely updates on technology transfers and site activities.
  • Assist with compiling and reviewing CMC sections of regulatory submissions and responses to regulatory inquiries.
  • Coordinate with lab units, supply chain, RACMC, and QA to foster collaboration and resolve issues within the Drug Substance team.

 

Requirements and Qualifications
  • Educational Background: Relevant degree within life science.
  • Industry Experience: Minimum of 5 years in the pharmaceutical/biotechnology industry.
  • Modalities: Must have experience in ADC & Bioconjugation / This is crucial.
  • Communication Skills: Excellent verbal and written communication skills in English, with the ability to work effectively in a multi-national, multi-cultural environment.
  • Leadership and Teamwork: Experience leading global projects and cross-functional teams, negotiating solutions, resolving conflicts, and aligning tasks with strategic organizational goals.
  • Operational Planning: Ability to contribute to operational planning, evaluate action priorities, and manage key functional processes.

 

This position requires a proactive leader with strong technical expertise, excellent communication skills, and the ability to navigate complex regulatory environments to ensure successful technology transfers and site launches. The estimated salary range for this position is $120,000 - $160,000 per year, depending on qualifications and experience.

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