Head of CMC

Barrington James; Bayern; Vor Ort; EUR 180.000 - 240.000; Vollzeit

Zusammenfassung

Barrington James is seeking a Head of CMC to lead global CMC strategy across both small molecule and biologics programmes, guiding regulatory submissions and cross-functional collaboration. This senior leadership role requires a strong track record in advancing complex development programmes through late-stage development and regulatory filing.

The ideal candidate will have 10–15+ years in CMC, pharmaceutical development, or technical operations, with extensive experience supporting NDA/BLA

Qualifikationen

• 10–15+ years within CMC, Pharmaceutical Development, or Technical Operations.
• Proven leadership across both small molecule and biologics modalities.
• Experience supporting NDA and/or BLA submissions.
• Strong regulatory interaction experience with health authorities.
• Familiarity with FDA/EMA regulatory requirements.
• Experience authoring or leading CTD Module 3 regulatory submissions.

Aufgaben

• Lead global CMC strategy and execution across small molecule and biologics development programmes.
• Provide strategic oversight of formulation, analytical, process development, manufacturing, and regulatory CMC activities.
• Drive CMC readiness for major regulatory milestones (IND, NDA, BLA).
• Lead preparation, review, and oversight of regulatory CMC documentation (Module 3).
• Manage internal teams and external partners (CDMOs, CROs, manufacturing partners).
• Support technology transfer, scale-up, process validation, and commercial readiness.

Kenntnisse

CMC leadership

Cross-functional leadership

Regulatory CMC knowledge

IND/NDA/BLA submissions

Global regulatory strategy

Project management

Jobbeschreibung

Head of CMC – Small Molecule & Biologics (Confidential Search)

Location: Confidential – disclosed following NDA execution and initial exploratory discussion

Experience Required: 10–15+ years within CMC, Pharmaceutical Development, and Regulatory CMC

About the Opportunity

We are supporting a confidential search on behalf of a rapidly growing pharmaceutical organisation seeking an experienced Head of CMC to lead global CMC strategy across both small molecule and biologics programmes.

This is a senior leadership opportunity for a CMC professional with a strong track record of advancing complex development programmes through late-stage clinical development and regulatory submission. The successful candidate will play a critical role in shaping CMC strategy, driving cross-functional collaboration, and ensuring successful delivery of high-quality regulatory submissions including BLA and NDA applications.

Further details regarding the organisation, location, and strategic objectives will be shared following NDA signature and an initial confidential conversation.

The Role

As Head of CMC, you will provide strategic and technical leadership across the full CMC lifecycle, partnering closely with R&D, Regulatory Affairs, Quality, Clinical, Manufacturing, and external partners.

Key responsibilities include:

• Lead global CMC strategy and execution across small molecule and biologics development programmes
• Provide strategic oversight of formulation development, analytical development, process development, manufacturing, and regulatory CMC activities
• Drive CMC readiness for major regulatory milestones, including IND, NDA, and BLA submissions
• Lead preparation, review, and oversight of regulatory CMC documentation, including Module 3 content
• Manage internal teams and external partners including CDMOs, CROs, and strategic manufacturing partners
• Support technology transfer, scale-up, process validation, and commercial readiness activities
• Ensure alignment of CMC strategies with FDA, EMA, and global regulatory expectations
• Act as a senior CMC representative with regulatory authorities and external stakeholders
• Build and develop high-performing CMC teams to support pipeline growth

Candidate Profile

We are seeking an accomplished CMC leader with significant experience delivering complex pharmaceutical programmes from early development through commercialisation.

• 10–15+ years of experience within CMC, Pharmaceutical Development, or Technical Operations
• Proven leadership experience across both small molecule and biologics modalities
• Strong understanding of end-to-end CMC development strategy
• Demonstrated experience supporting successful NDA and/or BLA submissions
• Extensive knowledge of FDA and EMA regulatory requirements
• Experience authoring, reviewing, or leading CTD Module 3 regulatory submissions
• Strong understanding of drug substance, drug product, analytical development, and manufacturing processes
• Experience managing external manufacturing partners, CDMOs, and development vendors
• Proven ability to operate effectively in a cross-functional, global environment
• Experience within a biotech, pharmaceutical, or specialty pharma environment
• Experience supporting late-stage clinical assets and commercial launches
• Experience working across multiple therapeutic areas
• Previous leadership of multidisciplinary CMC teams
• Strong regulatory interaction experience with health authorities

Why Consider This Opportunity?

This confidential appointment represents an opportunity to join an organisation at a significant stage of growth, where you will have the opportunity to influence CMC strategy, shape development programmes, and contribute directly to the advancement of innovative pharmaceutical products.