Senior CMC Program Lead — Biotech Ops & Cross-Functional PM

Socket.dev; South San Francisco (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Neurona Therapeutics, a subsidiary of UCB, is seeking a Senior Manager/Associate Director, CMC Project Management to lead integrated CMC planning and execution across technical operations supporting clinical supply, late-stage development, and commercial readiness.

You will partner with CMC, Manufacturing, Analytical, Quality, Regulatory, Supply Chain, Device, Engineering, and external partners to maintain integrated plans, track milestones, and communicate timelines and priorities clearly.

Qualifications

• Bachelor's in science/engineering; advanced degree preferred.
• 8–12 years biotech/pharma exp, incl 4–6 in CMC/Technical Operations.
• Experience coordinating complex cross-functional workstreams in regulated settings.
• Familiar with project planning and reporting tools (MS Project, Smartsheet, Excel).

Responsibilities

• Lead integrated CMC project management across cross-functional workstreams.
• Develop and maintain integrated project plans, dashboards, trackers.
• Facilitate cross-functional meetings, document decisions and actions.
• Identify critical paths, risks, and resource constraints; escalate as needed.
• Coordinate with external partners (CDMOs, CROs, labs, vendors) for deliverables.
• Support planning and tracking of CMC regulatory deliverables with stakeholders.
• Support program budgeting, forecasting, and financial reporting.
• Identify and implement process improvements for governance and execution.

Skills

Cross-functional collaboration

Stakeholder management

Communication

Facilitation

Leadership

Regulatory / GMP knowledge

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

Microsoft Project

Smartsheet

Excel

PowerPoint

Teams

SharePoint

Job description

Neurona Therapeutics, a subsidiary of UCB, is seeking a Senior Manager/Associate Director, CMC Project Management to lead integrated CMC planning and execution across technical operations supporting clinical supply, late-stage development, and commercial readiness.

You will partner with CMC, Manufacturing, Analytical, Quality, Regulatory, Supply Chain, Device, Engineering, and external partners to maintain integrated plans, track milestones, and communicate timelines and priorities clearly.