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

Real; München; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

A leading global pharmaceutical company is seeking an Associate Director, CMC - Drug Substance in Bavaria. You will manage the technology transfer and site launch of drug substance manufacturing processes, focusing on innovative therapies. This strategic role offers leadership opportunities and the chance to impact global patient care while benefiting from a collaborative culture and a modern work environment.

Leistungen

30 days of annual holiday

Hybrid work model

Cutting-edge infrastructure

Teamwork and integrity culture

Career growth opportunities

Qualifikationen

• Extensive experience in biopharmaceutical process development.
• Deep expertise in CMC development and technology transfer.
• Proven ability to lead global cross-functional teams.

Aufgaben

• Oversee technology transfer and launch of drug substance manufacturing processes.
• Act as primary technical interface between development and manufacturing sites.
• Collaborate with QA, Regulatory Affairs, Supply Chain, and Analytical Development.

Kenntnisse

Leadership

Communication

Negotiation

Risk Management

Data-driven decision-making

Ausbildung

Ph.D. or Master's degree in biochemistry, chemistry, pharmaceutical sciences, or related discipline

Jobbeschreibung

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.