CMC Project Manager Ellipses Pharma is a 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. The Role: Ellipses, driven by a robust pipeline of strong clinical candidates, is at an exciting stage of its evolution that promises business growth and the swift delivery of innovative medicines to patients. Reporting to the Head of CMC, the CMC Project Manager will be responsible for facilitating the successful planning, execution and delivery of the CMC projects across the Ellipses portfolio. The role will work collaboratively with all functions, in particular clinical development, and coordinate the activities of external parties to ensure that projects are delivered to plan and within the required compliance standards. Key Responsibilities: · Responsible for day-to-day management of external Contract Development and Manufacturing Organization(s) (CDMOs) across the Ellipses portfolio. · Facilitate successful project delivery, planning and execution of CMC projects to agreed program schedules and budgets. · Work with the Head of CMC to support the identification and selection of CDMOs, for the development, optimization, manufacture, and supply of Drug Substance and Drug Product across the Ellipse portfolio of pre-clinical and clinical phase programs. · Project Drug Substance and Drug Product needs for preclinical and clinical programs (with Clinical Operations) and manage supply chain and logistics in support of clinical studies · Liaise with key stake holders for scientific writing, where needed, and support reviews of pre-INDs, INDs, IMPDs, to support high-quality regulatory submissions · Act as the primary CMC point of contact for internal and external Stakeholders representing the CMC function at internal and external project team meetings. · Co-ordinate and support review of process documentation including: batch manufacturing records, protocols, reports, agreements, specifications, CoAs, deviations, change controls etc · Integration of the CMC project management approach across the Ellipses portfolio to enhance project delivery and information dissemination. · Anticipate CMC operational issues at the project level and influence solutions for similar issues across the portfolio Education & Experience: · A BSc, MSc or PhD in Life Sciences or equivalent. · 5–10 years’ experience in the biotech, pharmaceutical, or CDMO industry, with at least 3 years specifically in CMC development or manufacturing. · Proven industry experience of cGMPs (MHRA, US, EU,) for (bio)pharmaceuticals. · Experience in the regulatory and quality environment and associated guidelines as required for the development and manufacture of pharmaceutical and biopharmaceutical drug substances and drug products. · Hands-on experience with one or more of the following: Drug substance/drug product development, Tech transfer and scale-up, Regulatory submissions (e.g., IMPD, IND), working with CDMOs or CMOs. Skills & Attributes: · Ability to use a wide range of communication methods to ensure information is presented appropriately. · An influential and effective member of cross-functional teams or projects. · Plans ahead, using established tools, techniques and methodologies, to meet objectives and manage risk · Ability to liaise with others to ensure plans remain on schedule. · Problem solving - Actively seeks change that brings about improvement and innovation · Delivers high quality output by closely monitoring every process. · Competent and organised self-starter with the ability to perform multiple tasks concurrently. · Demonstrated ability to build effective relationships with, vendors and colleagues. · Excellent interpersonal and communication skills, both written and verbal · Self-motivated taking personal pride in delivering on personal and corporate objectives · Experience working effectively in a team/matrix environment · Ability to travel as required Interested candidates please apply with your CV and cover letter to
