CMC Associate Director/Director

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, and Asset Leader along with wider internal and external key collaborators and stakeholders.

Key Responsibilities:

•  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.
• ·Responsible for establishing and managing development, manufacturing, and supply chain activities across the portfolio including CDMO selection, qualification, and management, with support from external SMEs as needed
• Direct and manage CMC operational activities at third party suppliers
• Working with the Asset Leader, support the Clinical Trial Managers with the coordination and use of specific external CMC consultancies as appropriate to ensure timely delivery of all CMC activity in support of project delivery.
• Act as CMC technical author and lead for CMC sections of Regulatory submissions, briefing documents, and interactions with appropriate authorities.
• Responsible for the review of cGMP manufacturing batch records, CMC regulatory and quality documents. Prepare technical reports, publications and oral presentations. Work with the QP for batch release/ declaration and certification.
• Responsible for CMC project management and integration of the CMC plans into the Asset strategy including risk analysis and mitigation
• Contribute to the preparation of the annual budgets for CMC activity and track spend to ensure all activity is in line with the financial plans.
• Work with the business development team at Ellipses to provide expert CMC input into the review of potential new assets on which the company is conducting due diligence and may in-license

Skills and Experience

·      Life science degree or related discipline with a minimum of 5 years broad CMC sponsor side experience

·      Experience in the oncology therapy area would be desirable and of expedited development pathways (e.g. Breakthrough Therapy / Fast Track etc)

·      Significant experience within a biotech environment within a clinical trial sponsor organisation.

·      A drug product or drug substance specialist but with a sound understanding across the CMC lifecycle.

·      Confident acting as internal CMC expert across all asset types (preferably biologics) and able to utilise external expertise to support specific CMC requirements

·      Experience across pre-clinical, Phase 1 and Phase 2 trials

·      Experience in authoring CMC sections for regulatory filings and an ability to deal with complex CMC regulatory issues and requirements and proficient in interpreting international regulations

·      Demonstrate strong project management skills including planning, prioritisation, adherence to strict deadlines and managing multiple projects simultaneously with multiple external parties.

·      Experience of working internationally with partners and providers.