Manager, Drug Substance

We're partnered with a globally successful pharma organisation seeking a Manager of Drug Substance for its European development and production site in Munich. The company focuses on advancing innovative therapies across oncology, cardiovascular, rare disease, and immune-related areas. This role is responsible for leading technology transfer activities for drug substance manufacturing, particularly for complex biopharmaceutical products such as Antibody-Drug Conjugates from development through commercial production.

The position plays a critical role in ensuring seamless site launch, regulatory compliance, and cross-functional alignment through transition to routine manufacturing.

• Lead and coordinate site launch and technology transfer activities for drug substance manufacturing across internal and external production sites.
• Serve as the primary technical interface between global manufacturing sites, CDMOs, and internal cross‑functional stakeholders.
• Develop, communicate, and implement manufacturing and technology transfer plans aligned with cross‑functional CMC strategies and timelines.
• Review technical documentation (e.g., protocols, reports, PPQ documentation), support regulatory submissions, and provide inspection readiness and CAPA recommendations.
• Drive data‑based decision‑making by monitoring KPIs, conducting data analysis, and collaborating with digitalization teams to enhance manufacturing performance and mitigate risk.

• Ph.D. in biochemistry, chemistry, pharmaceutics, engineering, or a related field (or master’s degree with equivalent industry experience).
• Several years of experience in pharmaceutical or biotechnology process development, preferably within drug substance manufacturing.
• Strong expertise in CMC development, biopharmaceutical process development, technology transfer, regulatory requirements, and GMP compliance.
• Demonstrated experience leading global, cross‑functional project teams and managing complex site transfer initiatives.
• Excellent communication, stakeholder management, problem‑solving, and organizational skills in an international, matrixed environment.

If interested, apply to this job and reach out to Amit at