Senior CMC Project Lead: Cross-Functional Drug Development

BioSpace; South San Francisco (CA); On-site; USD 194,000 - 237,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Maze Therapeutics is seeking an Associate Director, CMC Project Management to drive cross-functional planning and execution across our pipeline programs. You will manage development and manufacturing timelines in collaboration with CMOs, partnering with CMC, Quality and internal stakeholders to enable milestones and regulatory success.

You will lead teams across Chemical Development, Pharmaceutical Development, CMC Analytical, QA, CMC Regulatory, and Clinical Supply Chain, owning risk management

Qualifications

• Bachelor's degree in life sciences, scientific, technical, engineering, or business discipline; advanced degree preferred.
• Minimum of 10 years total professional experience, with at least 5 years in project management in pharma/biotech/medical devices.
• At least 3 years directly managing cross-functional teams in a matrixed organization.
• Working knowledge of CMC and drug development functions across development lifecycle.
• Understanding of lifecycle through NDA/commercialization; GMP/GxP exposure; familiarity with quality systems.
• Proficiency with project management tools (Smart-sheet, MS Project, SharePoint, MS Office); PMP preferred.
• Strong organizational, prioritization, and communication skills; able to influence without formal authority.
• Ability to work independently and in startup/growth biotech settings; authorized to work in the U.S.

Responsibilities

• Provide end-to-end CMC project management across the drug development lifecycle.
• Lead cross-functional teams to plan and execute CMC activities aligned with goals.
• Facilitate meetings with CMOs and track action items.
• Own risk registries, mitigate risks, and escalate issues to protect timelines.
• Coordinate interdependencies across workstreams and govern CMC scope/status.
• Prepare proposals and analyses for senior leadership; resolve cross-team conflicts.
• Contribute to regulatory filings (IND, IMPD) in partnership with Regulatory CMC.
• Maintain dashboards, status reports, and meeting operations for stakeholders.
• Foster strong external partnerships and continuous improvement of PM processes.
• Support program-level budgeting and financial forecasting.

Skills

Cross-functional leadership

Program management

Communication

Risk management

Stakeholder management

Project governance

Organizational skills

Budget/forecasting

Education

Bachelor's degree in life sciences/engineering/business

Advanced degree preferred

Tools

Smart-sheet

Microsoft Project

SharePoint

Microsoft Office Suite

Job description

Maze Therapeutics is seeking an Associate Director, CMC Project Management to drive cross-functional planning and execution across our pipeline programs. You will manage development and manufacturing timelines in collaboration with CMOs, partnering with CMC, Quality and internal stakeholders to enable milestones and regulatory success.

You will lead teams across Chemical Development, Pharmaceutical Development, CMC Analytical, QA, CMC Regulatory, and Clinical Supply Chain, owning risk management