Director, CMC Program Management - Drug Product
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and CompanyAbout the role
<p><strong>Description of Role</strong></p> <p>Centessa is seeking a Director of CMC Program Management for Drug Product. The CMC PM will provide leadership and operational support to the development and manufacturing of our small molecule programs and actively engage with internal teams and external contract manufacturing organizations. The individual will drive effective execution of CMC deliverables by the project teams in coordination with and support of program and corporate goals. The ideal candidate should be highly organized and an exceptional communicator with experience leading early phase pre-IND teams through late-stage CMC Registration/Commercial validation and launch activities. Travel to vendors both domestically and internationally will be required.</p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Serve as the main point of contact for all CMC project-related communications especially focused on drug product development, manufacturing, release, packaging, labeling, and stability coordination</li> <li>Foster strong relationships with internal teams, and external partners including CDMOs.</li> <li>Participate in regular telecon meetings with CDMOs to maintain the business relationship, progress, meeting notes and action items.</li> <li>Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel.</li> <li>Support CMC activities including tracking relevant GMP and Regulatory documentation.</li> <li>Interfaces with drug substance, drug product, analytical, non-clinical, clinical, Regulatory, supply chain, and Quality colleagues to ensure all projects are delivered on time, within scope and budget.</li> <li>Work with CMC team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth and/or company timelines.</li> <li>Cover all other project management requirements including shipment/logistics coordination, inventory, and production planning.</li> <li>Drive the development and management of detailed and integrated development plans for CMC projects that account for all phases of drug development across functions with timelines, work plans including interdependencies, gating items, budget, and risk management strategies.</li> <li>Oversee the delivery of project objectives per the program strategy, with a strong focus on meeting critical milestones, and managing scope changes while integrating project constraints.</li> <li>Facilitate effective collaboration across CMC functional teams, ensuring alignment on project goals and priorities.</li> <li>Communicate project updates consistently to various stakeholders, about strategy, adjustments, and development progress.</li> <li>Experience
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Company
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and CompanyView company profile →