Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Senior Manager/Associate Director, CMC Project Management role.
Rezi rewrites your resume against Neurona Therapeutics's job description. Free.
Tailor your resume to this Senior Manager/Associate Director, CMC Project Management role.
Rezi rewrites your resume against Neurona Therapeutics's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Senior Manager/Associate Director, CMC Project Management posting at Neurona Therapeutics — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Senior Manager/Associate Director, CMC Project Management posting at Neurona Therapeutics — free, in seconds.
About the Role
Neurona Therapeutics is seeking a Senior Manager/Associate Director, CMC Project Management to lead integrated CMC project planning and execution across cross-functional technical operations teams supporting clinical supply, late-stage development, and commercial readiness. This role will partner closely with various teams to maintain integrated plans, track deliverables, identify risks, and support decision-making.
Responsibilities
- Lead integrated CMC project management across cross-functional technical operations workstreams, including CMC development, manufacturing, analytical development, quality, regulatory CMC, supply chain, device-related activities, engineering, and commercial readiness.
- Develop and maintain integrated project plans, timelines, milestone dashboards, action trackers, decision logs, risk registers, dependency maps, and meeting materials.
- Facilitate cross-functional team meetings by preparing agendas, documenting decisions and action items, tracking follow-up, and ensuring clear accountability.
- Identify critical path activities, cross-functional dependencies, risks, and resource constraints; support timely escalation and resolution of issues.
- Coordinate with external partners, including CDMOs, CROs, testing laboratories, device partners, engineering firms, and other vendors.
- Support planning and tracking of CMC regulatory deliverables, including submission-related inputs, health authority responses, and briefing materials.
- Support program budgeting, forecasting, resource planning, purchase order tracking, and financial reporting.
- Identify and implement process improvements to strengthen project execution, governance cadence, resource planning, reporting, and organizational effectiveness.
Requirements
- Bachelor's degree in a scientific, engineering, or related discipline required; advanced degree preferred.
- 8-12 years of biotech or pharmaceutical industry experience, including at least 4-6 years in CMC, Technical Operations, program management, project management, manufacturing, supply chain, regulatory CMC, quality, or a closely related function.
- Demonstrated experience coordinating complex technical workstreams across functional boundaries in a regulated development or manufacturing environment.
- Strong understanding of CMC development, GMP manufacturing, technical operations, external partner management, and cross-functional project execution.
- PMP certification, formal project management training, or equivalent demonstrated experience with integrated project planning, governance cadence management, risk management, and executive-ready reporting preferred.
- Experience with project planning, reporting, and tracking tools such as Microsoft Project, Smartsheet, Excel, PowerPoint, Teams, SharePoint, or equivalent systems.
- Excellent communication, facilitation, collaboration, and stakeholder management skills.
- Strong organizational skills, attention to detail, accountability, and ability to manage multiple priorities in a fast-paced environment.
- Cell or gene therapy experience preferred; familiarity with iPSC-derived, allogeneic, or advanced therapy medicinal product platforms, patient supply operations, device interfaces, GMP manufacturing, analytical control strategies, or commercial readiness activities is a plus.
Skills
- Project management
- CMC development
- GMP manufacturing
- Technical operations
- External partner management
- Cross-functional project execution
- Microsoft Project
- Smartsheet
- Excel
- PowerPoint
- Teams
- SharePoint
- Communication
- Facilitation
- Collaboration
- Stakeholder management
- Organizational skills
- Attention to detail
- Accountability
- Cell therapy
- Gene therapy
Location
- South San Francisco, CA, 94080
Work Type
- Full Time
- On-Site
Experience Level
- Senior Manager/Associate Director
- 8-12 years of biotech or pharmaceutical industry experience
- 4-6 years in CMC, Technical Operations, program management, project management, manufacturing, supply chain, regulatory CMC, quality, or a closely related function
Education Level
- Bachelor's degree in a scientific, engineering, or related discipline
- Advanced degree preferred
About the Company
- Neurona Therapeutics, a wholly owned subsidiary of UCB, is developing transformative cell therapies for patients with serious neurological diseases.