CMC Program Lead — Associate Director, Project Management

Enigma Search; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Enigma Search in California seeks an Associate Director, CMC Project Management to lead cross-functional planning across development programs, driving CMC strategy, timelines, and manufacturing activities in partnership with external CMOs.

You will collaborate with Quality, Regulatory, Clinical Supply, and Program Management to enable milestones, support regulatory submissions, and advance programs through the drug development lifecycle.

Qualifications

• Bachelor's degree or equivalent in a life sciences, engineering, or related field.
• Advanced degree is preferred for higher involvement in strategy.
• PMP certification is a plus for program management.

Responsibilities

• Provide end-to-end CMC project management across development stages.
• Lead cross-functional teams across development, quality, regulatory, and supply chain to deliver program objectives.
• Serve as liaison for CMOs, manage deliverables and drive action-item follow-through.
• Own program-level risk management including mitigation and escalation.
• Support regulatory submissions planning and governance materials for leadership decisions.
• Communicate via project plans, dashboards, and status reports to stakeholders.
• Foster partnerships with internal teams and external vendors to ensure execution.

Skills

Cross-functional leadership

Stakeholder management

Communication skills

Time management

Education

Bachelor's degree in life sciences, engineering, scientific, technical, or business

Advanced degree preferred

PMP certification

Tools

Smartsheet

Microsoft Project

SharePoint

Microsoft Office

Job description

Enigma Search in California seeks an Associate Director, CMC Project Management to lead cross-functional planning across development programs, driving CMC strategy, timelines, and manufacturing activities in partnership with external CMOs.

You will collaborate with Quality, Regulatory, Clinical Supply, and Program Management to enable milestones, support regulatory submissions, and advance programs through the drug development lifecycle.