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.

Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.