Associate Director CMC (Drug Substance - ADC) (m / w / d)

On behalf of our client-a leading global pharmaceutical company with multi-billion-euro backing-we are supporting the expansion of a state-of-the-art manufacturing site in Bavaria. This site is poised to become a center of excellence for breakthrough therapies in cardiovascular disease and oncology.

We are currently looking for an exceptional candidate to join their team as Associate Director, CMC - Drug Substance (ADC) (m / w / d)

You will oversee the technology transfer and site launch of drug substance manufacturing processes-particularly Antibody-Drug Conjugates-from development to routine production, ensuring alignment, risk management, and technical support across internal and external manufacturing sites.

Key Responsibilities :

• Lead and coordinate site launch initiatives and cross-functional sub-teams for both internal and external manufacturing sites.
• Oversee the end-to-end technology transfer of drug substance processes, ensuring alignment with CMC strategy, regulatory expectations, and GMP standards.
• Act as the primary technical interface between development, manufacturing, and CDMO partners.
• Review and approve technical documentation including protocols, validation reports, and PPQ documentation.
• Conduct scouting and evaluation of CDMOs for clinical and commercial manufacturing.
• Drive data-driven decision-making, performance monitoring, and digital data integration in collaboration with the Tech Strategy team.
• Recommend and implement CAPAs, support inspections, and proactively mitigate technical risks.
• Contribute to the preparation and review of CMC sections for global regulatory submissions (INDs, IMPDs, NDAs, BLAs).
• Collaborate with cross-functional teams including QA, Regulatory Affairs, Supply Chain, and Analytical Development to ensure project success.

Your Profile :

• Ph.D. or Master's degree in biochemistry, chemistry, pharmaceutical sciences, or a related discipline.
• Extensive experience in biopharmaceutical process development, ideally with a focus on drug substance manufacturing.
• Deep expertise in CMC development, technology transfer, and GMP compliance, particularly for biologics and complex modalities such as ADCs.
• Proven ability to lead global cross-functional teams and manage external manufacturing partnerships.
• Strong communication, negotiation, and leadership skills in a multicultural, matrixed environment.
• Fluent in English; German is an advantage.

What's in It for You?

• Strategic impact - Play a key role in bringing innovative biologics and ADCs to patients worldwide.
• Leadership opportunity - Lead high-priority programs with global visibility and cross-functional influence.
• Collaborative culture - Join a company that values teamwork, integrity, and scientific excellence.
• Modern work environment - Be part of a forward-thinking organization with a hybrid work model and cutting-edge infrastructure.
• Work-life balance - Enjoy 30 days of annual holiday and the lifestyle benefits of living in Bavaria.
• Career growth - Be part of a rapidly expanding organization with clear pathways for advancement.