CMC Lead Formulation (w/m/d)

Progressive / SThree Group; München; Vor Ort; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

Progressive / SThree Group in Germany is seeking a CMC Lead Formulation Development (w/m/d) to provide scientific, strategic, and people leadership in a cutting‑edge biopharma environment, focusing on ADCs and complex biologics from early development to commercialization.

You will lead a global formulation development team, shape design and process development, oversee technology transfer to sites and CDMOs, support regulatory submissions, and mentor talent to foster an inclusive,

Qualifikationen

• PhD required or equivalent with extensive formulation/CMC experience.
• 10+ years in formulation development and biologics.
• Proven track record advancing programs to commercialization.
• Experience with global regulatory submissions (BLA).
• Line management experience and team development.
• Strong leadership and communication in global matrix.

Aufgaben

• Lead formulation design, process development, and manufacturing strategy.
• Establish robust manufacturing processes and control strategies for complex biologics.
• Oversee technology transfer to internal sites and external CDMOs across Europe.
• Support lifecycle management and product optimization for commercial programs.
• Provide strategic CMC leadership for global development programs and regulatory submissions.
• Collaborate with R&D, Regulatory, Quality, Manufacturing, and Supply Chain teams.
• Develop departmental strategies, operating plans, and resource allocation.
• Mentor scientific talent and foster an inclusive, high-performing culture.

Kenntnisse

Leadership

Strategy

Stakeholder mgmt

English fluency

Cross-functional

Regulatory submissions

Project mgmt

Ausbildung

PhD in Pharmacy

MSc in Pharma

Jobbeschreibung

CMC Lead Formulation Development (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.