CMC Program Director, Biotech Operations

Neurona Therapeutics; South San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Neurona Therapeutics, a neuroscience-focused cell therapy company, is seeking a Senior Manager/Associate Director, CMC Project Management to lead integrated CMC planning and execution across multiple cross-functional teams supporting clinical supply, late-stage development, and commercial readiness.

This role collaborates with CMC, Manufacturing, Analytical, Quality, Regulatory, and Supply Chain, driving timelines, milestones, and decision-making, while guiding budget tracking and process

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline.
• 8–12 years biotech/pharma industry experience, incl. 4–6 years in CMC/Technical Operations/PM roles.
• PMP certification or equivalent taught/experienced preferred.
• Experience with MS Project/Smartsheet/Excel/PowerPoint/Teams/SharePoint or equivalent tools.

Responsibilities

• Lead integrated CMC project management across cross-functional workstreams (CMC development, manufacturing, analytical, quality, regulatory CMC, supply chain, device, engineering, commercial readiness).
• Develop and maintain integrated project plans, timelines, dashboards, action trackers, and risk registers to support execution.
• Coordinate with external partners (CDMOs, CROs, labs, device partners) to support manufacturing, testing, supply, and readiness.
• Support CMC regulatory deliverables and budgeting/tracking to enable program execution.

Skills

Project management

Cross-functional collaboration

Stakeholder management

Communication

Education

Bachelor's degree

Advanced degree preferred

Tools

Microsoft Project

Smartsheet

Excel

PowerPoint

Teams

SharePoint

Job description

Neurona Therapeutics, a neuroscience-focused cell therapy company, is seeking a Senior Manager/Associate Director, CMC Project Management to lead integrated CMC planning and execution across multiple cross-functional teams supporting clinical supply, late-stage development, and commercial readiness.

This role collaborates with CMC, Manufacturing, Analytical, Quality, Regulatory, and Supply Chain, driving timelines, milestones, and decision-making, while guiding budget tracking and process