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

Progressive; München; On-site; EUR 180,000 - 240,000; Full time

Job summary

Progressive is seeking a senior leader to head Formulation Development for Drug Product, guiding CMC strategy and global development programs in a cutting-edge environment. The role focuses on biologics, ADCs, and complex modalities with substantial strategic influence.

The candidate will lead a global team, manage technology transfer, and drive regulatory submissions while shaping development plans from early-stage to commercialization. Fluency in English required; German beneficial.

Qualifications

• PhD in Pharmacy or related field (or MSc with substantial industry experience).
• 10+ years in formulation development, CMC, or biologics areas.
• Strong track record in product development and advancement to commercialization.
• Deep knowledge of global CMC requirements, GMP, and quality systems.
• Experience supporting regulatory submissions (INDs, BLAs, NDAs).
• Past line management and talent development experience.

Responsibilities

• Lead formulation development strategy and team leadership for complex biologics.
• Drive formulation design, process development, and manufacturing strategy.
• Establish robust processes, control strategies, and formulations for clinical and commercial programs.
• Oversee technology transfer to internal sites and CDMO partners across regions.
• Guide CTM manufacturing activities and ensure alignment with quality and regulatory requirements.
• Provide CMC leadership for global development programs and regulatory submissions.
• Collaborate with R&D, Regulatory, QA, Manufacturing, and Supply Chain teams.
• Mentor scientific talent and foster a high-performing, inclusive culture.

Skills

Formulation Development

CMC Development

Biologics Development

Technology Transfer

Regulatory Submissions

Leadership

Education

PhD in Pharmacy or related

Job description

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.

Desired Skills and Experience

• Formulation Development
• Drug Product Development
• Pharmaceutical Development
• Biologics Development
• Antibody Drug Conjugates (ADC)
• Bioconjugates
• Protein Formulation
• Sterile Formulation
• Injectable Development
• Parenteral Drug Products
• Lyophilization
• Drug Product CMC
• Product Development
• Pharmaceutical Technology
• Process Development
• Manufacturing Science
• Technology Transfer
• Clinical Trial Material (CTM)