Head of Formulation Development - Drug Product (w/m/d)

Head of Formulation Development - Drug Product (w/m/d)

Location: Germany | Industry: Innovative Biopharmaceuticals | Leadership Level: Senior Management

A leading global biopharmaceutical organization is seeking an experienced CMC Lead Formulation Development to provide scientific, strategic, and people leadership within a cutting-edge research and development environment. This role offers the opportunity to drive formulation and process development for advanced biologics, including antibody-drug conjugates (ADCs), while playing a key role in global development programs from early-stage development through commercialization.

Key Responsibilities

• Lead and develop a highly skilled formulation development team, providing both technical and people leadership.
• Drive formulation design, process development, and manufacturing strategy for complex biologic products and novel therapeutic modalities.
• Establish robust manufacturing processes, control strategies, and product formulations to support successful clinical and commercial development.
• Lead technology transfer activities to internal manufacturing sites and external CDMO partners across Europe.
• Oversee clinical trial material (CTM) manufacturing activities and ensure execution in line with quality, regulatory, and project requirements.
• Support lifecycle management initiatives for commercial products and contribute to ongoing product optimization.
• Provide strategic CMC leadership for global development programs, including preparation and support of regulatory submissions such as INDs, NDAs, BLAs, and post-approval variations.
• Collaborate with multidisciplinary global teams across R&D, Regulatory Affairs, Quality, Manufacturing, and Supply Chain.
• Develop and execute departmental strategies, annual operating plans, resource allocation, and performance objectives.
• Mentor and develop scientific talent while fostering a high-performing, inclusive, and innovative team culture.

Qualifications

• PhD in Pharmacy, Pharmaceutical Sciences, Life Sciences, Engineering, or a related discipline; alternatively a Master's degree with substantial relevant industry experience.
• Extensive pharmaceutical industry experience (typically 10+ years) in formulation development, CMC development, biologics development, or related functions.
• Proven track record in product development and successful advancement of pharmaceutical programs from development through commercialization.
• Strong understanding of global CMC requirements, formulation sciences, technology transfer, GMP regulations, and quality systems.
• Demonstrated experience supporting or leading major regulatory submissions, including BLA filings.
• Previous line management experience with responsibility for team development and performance management.
• Strong leadership, stakeholder management, and communication skills.
• Experience operating successfully within complex global matrix organizations.
• Fluency in English, both written and spoken.

Why This Opportunity?

This is an exceptional opportunity to join a highly innovative biopharmaceutical company at the forefront of next-generation therapies. The position offers significant strategic influence, international visibility, leadership responsibility, and the chance to shape the future of advanced medicines that address serious unmet medical needs worldwide.