Crescent Biopharma
Manager, CMC Project Management
Waltham, MA
Sponsorship not specified$140k-$180kDetected 1 day ago
Project ManagementFinancial AnalysisForecastingBudgetingSupply ChainGMPCommunicationCollaborationFinancial Reporting
About the role
- For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
- Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
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.
- Partner with CDMOs, CROs, testing laboratories, and other external vendors to monitor deliverables, manufacturing activities, timelines, and issue resolution.
- 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.
- Familiarity with GMP manufacturing and external partner management.
- Ability to manage multiple priorities in a fast-paced environment.
- Ability to identify risks and drive issue resolution.
- The Company's clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates.
- 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.
Requirements
- Bachelor's degree in a scientific, engineering, or related discipline required.
- Experience with project planning and tracking tools.
- This role is based in Waltham, MA and you must have experience in the oncology space.
Compensation
- $140k-$180k
Benefits
- Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients.
- Coordinate planning and execution of CMC regulatory submissions, including INDs, IMPDs, amendments, and health authority responses, ensuring cross-functional deliverables are completed on schedule.
- Education & Experience
Company info
- We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected.
Equal opportunity
- Equal Opportunity Employer.
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