Manager, CMC Operations Program Management
$125,000–$165,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead cross-functional CMC activities by building relationships with internal SMEs and external partners to drive program goals and accountabilities. Develop, maintain, and track detailed project plans, Gantt charts, and budgets with key milestones aligned to overall objectives. Facilitate internal and partner meetings to ensure effective decision-making, proactively identify risks and resource bottlenecks, and implement mitigation plans. Generate dashboards for program updates, maintain risk registers and decision logs, and prepare content for Joint Leadership Meetings. Support process standardization, KPI management, and weekly 1:1s with partners to ensure milestone adherence. Collaborate with finance and department leads for invoicing.
Required Qualifications
- S. in a scientific or engineering discipline
- 3 or more years of relevant experience in the CMC environment
- cGMP program management experience
Desired Qualifications
- Cell/gene therapy preferred
- Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products
- Extensive experience is leading product/process program within a GMP setting
- Program management skills, including strategic and tactical programs/tasks, tracking and adhering to budgets, reporting program and campaign metrics, and other program management tools
- Strong verbal and written skills
- effective interpersonal, technical, and troubleshooting skills
- Outstanding planning, organization, and multitasking skills
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