CMC Lead (Biologics)

We are supporting an innovative and well-funded biopharmaceutical organisation in Switzerland that is advancing a strong pipeline of biologic therapeutics.

They are seeking a CMC Lead to take ownership of end-to-end product development strategy, working cross-functionally to progress assets from clinical development through to commercialisation.

This is a highly visible role, sitting at the interface of process development, manufacturing, regulatory affairs, and quality, with direct impact on program strategy and delivery.

Key Responsibilities

• Lead CMC strategy across the full product lifecycle (early development through late-stage and commercial readiness)
• Act as CMC Product Lead, coordinating cross-functional teams across Process Development, Manufacturing, Quality, and Regulatory
• Drive and oversee technology transfer activities (internal and external CDMOs), ensuring successful scale-up and GMP readiness
• Provide strategic oversight of manufacturing operations, including process performance, control strategy, and lifecycle management
• Lead the preparation and review of regulatory submissions (IND, IMPD, BLA/MAA), including Module 3 content
• Own gap analysis, risk assessment, and mitigation strategies to support clinical and commercial timelines
• Interface with global health authorities, supporting responses to regulatory queries and inspections
• Manage external partners (CDMOs, CROs), ensuring delivery against timelines, quality, and budget
• Contribute to long-term CMC and supply chain strategy, including process optimisation and cost of goods considerations

• Extensive experience in CMC / Process Development within biologics or advanced therapies
• Proven track record as a CMC Lead or technical lead on regulatory filings (IND/IMPD and ideally BLA/MAA)
• Strong background in manufacturing and GMP environments, including scale-up and commercial readiness
• Demonstrated experience leading technology transfer activities across sites and/or CDMOs
• Deep understanding of process validation, control strategies, and regulatory expectations
• Experience working in cross-functional, matrix environments with senior stakeholder exposure
• Strong leadership and communication skills, with the ability to influence at multiple levels