Senior Manager/Associate Director, CMC Project Management

Senior Manager/Associate Director, CMC Project Management 

Location: South San Francisco, CA, 94080

Job Type: Full Time

Work Type: On-Site

Position Summary Neurona Therapeutics, a wholly owned subsidiary of UCB, is developing transformative cell therapies for patients with serious neurological diseases. We are 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 CMC, Manufacturing, Analytical, Quality, Regulatory, Supply Chain, Device, Engineering, and external partner teams to maintain integrated plans, track key deliverables, identify risks and dependencies, support decision-making, and provide clear visibility to timelines, milestones, and execution priorities. Key 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 to support effective execution and transparent communication.
• Facilitate cross-functional team meetings by preparing agendas, documenting decisions and action items, tracking follow-up, and ensuring clear accountability for deliverables and timelines.
• Identify critical path activities, cross-functional dependencies, risks, and resource constraints; support timely escalation and resolution of issues requiring leadership input or cross-team alignment.
• Coordinate with external partners, including CDMOs, CROs, testing laboratories, device partners, engineering firms, and other vendors, to support manufacturing, testing, supply, facility readiness, and related project deliverables.
• Support planning and tracking of CMC regulatory deliverables, including submission-related inputs, health authority responses, briefing materials, and other regulatory commitments in collaboration with Technical Operations, Regulatory, and Quality stakeholders.
• Support program budgeting, forecasting, resource planning, purchase order tracking, and financial reporting to enable effective execution of CMC development and technical operations activities.
• Identify and implement process improvements to strengthen project execution, governance cadence, resource planning, reporting, and organizational effectiveness.

Qualifications

• 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, including the ability to work effectively with cross-functional teams and senior leaders.
• 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.

Alert
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