Posted 2 months ago
Manager, CMC Project Management
Waltham, MAOn-siteFull-time
AI Summary
Manager, CMC Project Management at Crescent Biopharma leads cross-functional CMC project execution for oncology clinical programs, coordinating planning, risks, timelines, and regulatory deliverables.
About this role
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
We are seeking a Manager, CMC Project Management who is responsible for driving cross-functional execution of CMC activities in support of early and late-stage clinical development programs. Working closely with Technical Operations - including Drug Substance, Drug Product, Analytical Development, Regulatory CMC, Quality, Supply Chain and external partners, this role leads integrated project planning, facilitates cross-functional alignment, manages risks and timelines, and enables successful delivery of CMC milestones in support of regulatory and development objectives. This role is based in Waltham, MA and you must have experience in the oncology space.
Responsibilities
- Lead cross-functional CMC project management for clinical-stage development programs, developing and maintaining integrated project plans, timelines, critical path activities, milestones, risks, and decision logs.
- Drive project execution by facilitating cross-functional meetings, tracking actions and decisions, proactively identifying risks and dependencies, and escalating issues to ensure program objectives are achieved.
- Coordinate activities across Drug Substance, Drug Product, Analytical Development, Quality Control, Quality Assurance, Supply Chain, Regulatory CMC, and other Technical Operations functions to ensure alignment of priorities and deliverables
- Partner with CDMOs, CROs, testing laboratories, and other external vendors to monitor deliverables, manufacturing activities, timelines, and issue resolution.
- Coordinate planning and execution of CMC regulatory submissions, including INDs, IMPDs, amendments, and health authority responses, ensuring cross-functional deliverables are completed on schedule.
- Support program budgeting, forecasting, resource planning, purchase order tracking, and financial reporting to enable effective execution of CMC development activities.
- Identify and implement process improvements to strengthen CMC project execution, governance, resource planning, and organizational effectiveness.
Education & Experience
What We Offer
Skills
Analytical DevelopmentCMCDrug ProductDrug SubstanceGMP ManufacturingProject PlanningProject TrackingQuality ControlRegulatory CMCRisk Management
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