CMC Lead Formulation (w/m/d)

Progressive; München; Vor Ort; EUR 150.000 - 210.000; Vollzeit

Zusammenfassung

Progressive, a leading biopharmaceutical organization, seeks a CMC Lead Formulation Development to drive strategy and execution for advanced biologics, including ADCs, from early development to commercialization.

The role combines scientific leadership with people management, global collaboration, and strategic regulatory support, in a cutting-edge R&D environment. Fluency in English is required and the position is based in Germany.

Qualifikationen

• PhD or equivalent with strong formulation and CMC expertise.
• 10+ years in formulation development and biologics.
• Experience leading regulatory submissions (BLA) and cross-functional teams.
• Leadership experience with team development and performance management.
• Fluency in English (written and spoken).

Aufgaben

• Lead and develop a formulation development team with people leadership.
• Drive design, process development and manufacturing strategy for complex biologics.
• Establish robust manufacturing processes and control strategies.
• Lead tech transfer to internal sites and CDMOs across Europe.
• Oversee CTM manufacturing for trials; ensure quality and regulatory alignment.
• Support lifecycle management and product optimization.
• Provide strategic CMC leadership for global development programs and regulatory filings.
• Collaborate with R&D, Regulatory, Quality, Manufacturing, and Supply Chain.
• Develop departmental strategies, budgets, resources, and performance objectives.
• Mentor scientific talent and foster an inclusive high-performing culture.

Kenntnisse

Leadership

English fluency

Strategic thinking

Communication

People management

Ausbildung

PhD in Pharmacy, Pharmaceutical Sciences, Life Sciences, Engineering, or related

Master's degree with substantial relevant industry experience

Jobbeschreibung

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)