CMC Associate Director/Director

JR United Kingdom; London; On-site; GBP 80,000 - 140,000; Full time

Job summary

A major player in oncology development seeks a CMC Director to oversee all CMC-related activities for a portfolio of assets. The role demands a strong scientific background, with responsibilities spanning drug development to regulatory strategies. This position offers an exciting opportunity to lead CMC operations in a dynamic biotech environment, working closely with cross-functional teams.

Qualifications

• 5+ years of broad CMC experience on the sponsor side.
• Experience in oncology therapy and expedited development pathways is desirable.
• Experience in clinical trial sponsor organizations.

Responsibilities

• Lead CMC-related activities for drug development and supply.
• Manage development and supply chain activities across the portfolio.
• Act as CMC technical author for regulatory submissions.

Skills

Project management

Regulatory expertise

Drug product knowledge

Oncology experience

Collaboration

Education

Life science degree or related discipline

Job description

Ellipses Pharma is a global drug development company headquartered in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group, which comprises more than 300 leading oncologists, and an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.

Reporting to the Head of CMC, the CMC Director will have responsibility for all CMC-related activities across the Ellipses portfolio of assigned pre-clinical and clinical assets. The role will work closely with the Clinical Operations team, Head of Translational Medicine, Asset Leader, and wider internal and external stakeholders.

Key Responsibilities:

1. Develop and lead CMC-related activities for drug substance and drug product development, manufacture, and supply, from in-license through to clinical development and registration/out-license for assigned assets.
2. Establish and manage development, manufacturing, and supply chain activities across the portfolio, including CDMO selection, qualification, and management, with support from external SMEs as needed.
3. Direct and manage CMC operational activities at third-party suppliers.
4. Support Clinical Trial Managers with coordination and use of external CMC consultancies to ensure timely delivery of all CMC activities supporting project delivery.
5. Act as CMC technical author and lead for CMC sections of regulatory submissions, briefing documents, and interactions with authorities.
6. Review cGMP manufacturing batch records, CMC regulatory and quality documents. Prepare technical reports, publications, and oral presentations. Collaborate with QP for batch release, declaration, and certification.
7. Manage CMC projects and integrate CMC plans into the Asset strategy, including risk analysis and mitigation.
8. Contribute to annual budgets for CMC activities and track spending to ensure alignment with financial plans.
9. Work with the business development team to provide CMC input during due diligence for potential new assets.

Skills and Experience:

• Life science degree or related discipline with at least 5 years of broad CMC sponsor-side experience.
• Experience in oncology therapy area and expedited development pathways (e.g., Breakthrough Therapy, Fast Track) is desirable.
• Significant experience within a biotech environment within a clinical trial sponsor organization.
• Specialist in drug product or drug substance with a sound understanding of the CMC lifecycle.
• Confident as an internal CMC expert across asset types (preferably biologics) and able to leverage external expertise.
• Experience across pre-clinical, Phase 1, and Phase 2 trials.
• Proficient in authoring CMC sections for regulatory filings and handling complex regulatory issues, interpreting international regulations.
• Strong project management skills, including planning, prioritization, meeting deadlines, and managing multiple projects with external partners.
• Experience working internationally with partners and providers.