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Location: London / 3 days a week onsite.
Travel: Frequent travel to EU for beginning of programme / So flexibility is needed.
An innovative biotechnology company developing cutting-edge cell therapies, is seeking an experienced CMC Lead to guide all Chemistry, Manufacturing and Controls (CMC) activities as the company advances its lead candidate into the clinic. This role offers the opportunity to make a significant impact at a pivotal stage of development.
The Role
The CMC Lead will take overall responsibility for defining and executing CMC strategy, ensuring the seamless transition of a novel cell therapy from preclinical research into first-in-human clinical trials. Acting as the primary point of contact for CMC, the successful candidate will coordinate internal stakeholders and external partners to deliver high-quality GMP material and regulatory submissions on time.
Key Responsibilities
* Lead all CMC activities, covering process development, GMP manufacturing, analytical development, and supply chain.
* Define and implement the CMC strategy for the company’s lead cell therapy program, supporting IND/CTA submissions and early clinical trials.
* Manage relationships with external CDMOs/CMOs to ensure reliable GMP manufacturing and supply.
* Oversee analytical development and quality control, including method development, validation, and release testing.
* Contribute to CMC sections of regulatory submissions (IND/CTA, IMPD) and ensure compliance with global regulatory requirements.
* Monitor project timelines, budgets, and resources, providing clear reporting to leadership.
* Collaborate with R&D, Regulatory, Clinical, and Quality functions to ensure cross-functional alignment.
* Build and mentor a growing internal CMC function as the pipeline expands.
Candidate Profile
* PhD or MSc in Biotechnology, Biochemical Engineering, Cell & Molecular Biology, or a related discipline.
* 7+ years of relevant industry experience, ideally in cell or gene therapy CMC.
* Strong understanding of GMP requirements for advanced therapy products.
* Proven track record of managing CDMOs/CMOs and delivering material for early clinical programs.
* Experience preparing CMC documentation for IND/CTA submissions.
* Excellent project management and communication skills; able to lead in a cross-functional, fast-paced environment.
The Opportunity
This is an exceptional opportunity for an experienced CMC leader to join a pioneering biotech at a critical inflection point. The role offers significant visibility, impact, and career development, with the chance to shape CMC strategy for first-in-class therapies.
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