CMC Associate Director/Director

JR United Kingdom; Slough; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading company in drug development seeks a CMC Director to oversee CMC-related activities across its portfolio. This pivotal role requires strong project management skills, extensive CMC lifecycle expertise, and a collaborative approach to work with various stakeholders in the oncology sector.

Qualifications

• At least 5 years of CMC sponsor-side experience.
• Experience in managing CMC lifecycle for drug products.
• Ability to work internationally with partners and providers.

Responsibilities

• Lead CMC activities for drug substance and drug product development.
• Manage development and supply chain activities.
• Act as CMC technical author for regulatory submissions.

Skills

Project Management

CMC Lifecycle Expertise

Oncology Experience

Regulatory Knowledge

Collaboration

Education

Life Science Degree

Job description

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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. This model combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group comprising over 300 leading oncologists, and uninterrupted funding to minimize the time to advance lead products through clinical trials and reach patients.

Position: CMC Director

Reporting to the Head of CMC, the CMC Director will oversee all CMC-related activities across Ellipses' portfolio of pre-clinical and clinical assets. The role involves close collaboration with the Clinical Operations team, Head of Translational Medicine, Asset Leader, and other internal and external stakeholders.

Key Responsibilities:

1. Develop and lead CMC activities for drug substance and drug product development, manufacture, and supply, from in-license through clinical development and registration/out-licensing for assigned assets.
2. Establish and manage development, manufacturing, and supply chain activities, 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 in coordinating external CMC consultancies to ensure timely delivery of CMC activities supporting project milestones.
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, and prepare technical reports, publications, and presentations. Work with the QP for batch release and certification.
7. Manage CMC projects and integrate CMC plans into the Asset strategy, including risk analysis and mitigation.
8. Contribute to annual budgeting for CMC activities and monitor expenditure to align with financial plans.
9. Collaborate with the business development team to provide CMC expertise 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 and expedited development pathways (e.g., Breakthrough Therapy, Fast Track) is desirable.
• Significant biotech experience within a clinical trial sponsor organization.
• Specialist in drug product or drug substance with a comprehensive understanding of the CMC lifecycle.
• Ability to serve as an internal CMC expert across asset types, preferably biologics, utilizing external expertise as needed.
• Experience across pre-clinical, Phase 1, and Phase 2 trials.
• Proficiency in authoring CMC sections for regulatory filings and managing complex regulatory issues.
• Strong project management skills, including planning, prioritization, and managing multiple projects with strict deadlines and external partners.
• Experience working internationally with partners and providers.