CMC Leadership: Associate Director, Cross-Functional PM

mazetherapeutics

South San Francisco (CA)

On-site

USD 180,000 - 240,000

Full time

5 days ago
Be an early applicant
Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Maze Therapeutics is seeking an Associate Director, CMC Project Management to drive cross-functional planning and execution across our development programs. In this highly visible role, you will manage development and manufacturing timelines with CMOs, partner with CMC, Quality, Regulatory, and Clinical Supply Chain to enable milestones and regulatory success.

Reporting to the VP, Technical Operations, you will own risk management, prepare governance materials, support IND/IMPD filings, and

Qualifications

  • At least 10 years of professional experience in pharma/biotech with 5+ years in PM.
  • Proven track record leading cross-functional teams in matrixed orgs.
  • Knowledge of CMC, drug development processes, and GMP/GxP environments.
  • Experience with regulatory CMC filings and collaboration with CMOs and QA.
  • Strong communication and stakeholder influence across teams.

Responsibilities

  • Provide end-to-end CMC PM support across drug development.
  • Lead cross-functional teams to plan and execute CMC activities.
  • Serve as main point of contact with CMOs and follow up actions.
  • Own risk management - registries, mitigation, escalation.
  • Coordinate with Program Management on CMC scope and interdependencies.
  • Prepare proposals and analyses for governance and leadership reviews.
  • Support regulatory filing planning (IND/IMPD) with Regulatory CMC.
  • Deliver dashboards and status reports for stakeholders.
  • Foster collaboration with external partners to resolve issues.
  • Champion process improvement and budget forecasting.

Skills

Project management
Cross-functional leadership
Communication
Risk management
Budgeting & forecasting
Stakeholder management
Process improvement

Education

Bachelor's degree in life sciences or related field
Advanced degree preferred

Tools

SmartSheet
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 development programs. In this highly visible role, you will manage development and manufacturing timelines with CMOs, partner with CMC, Quality, Regulatory, and Clinical Supply Chain to enable milestones and regulatory success.

Reporting to the VP, Technical Operations, you will own risk management, prepare governance materials, support IND/IMPD filings, and

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Associate Director, CMC Project Management
Associate Director, CMC Project Management

mazetherapeutics • South San Francisco (CA)

On-site
USD 180,000 - 240,000
CMC Program Lead — Associate Director, Project Management
CMC Program Lead — Associate Director, Project Management

Enigma Search • South San Francisco (CA)

On-site
USD 180,000 - 240,000
Associate Director, CMC Project Management
Associate Director, CMC Project Management

Enigma Search • South San Francisco (CA)

On-site
USD 180,000 - 240,000
Senior Manager, Chemical Development & CMO Leadership
Senior Manager, Chemical Development & CMO Leadership

Initial Therapeutics, Inc. • South San Francisco (CA)

Hybrid
USD 158,000 - 193,000
Equity incentive plan
401(k) with employer match
Health/Dental/Vision insurance
+1
Senior Manager, Chemical Development & CMO Partnerships
Senior Manager, Chemical Development & CMO Partnerships

Maze Therapeutics • South San Francisco (CA)

Hybrid
USD 158,000 - 193,000
Equity incentive plan
401(k) with employer match
Medical, dental, vision insurance
CMC Project Leadership: Associate Director
CMC Project Leadership: Associate Director

Merck & Co. • North Wales

Hybrid
USD 142,000 - 224,000
CMC Program Director: Site Operations & Delivery
CMC Program Director: Site Operations & Delivery

Scorpion Therapeutics • Indianapolis (IN)

On-site
USD 203,000 - 246,000
Health & wellbeing programs
Financial protection (401k, insurance)
CMC Project Manager — Drug Development & Launch Readiness
CMC Project Manager — Drug Development & Launch Readiness

Intuitive • Sunnyvale (CA)

On-site
USD 128,000 - 151,000
Senior Director, CMC Lead Product Development
Senior Director, CMC Lead Product Development

Scorpion Therapeutics • United States

On-site
USD 160,000 - 220,000
Strategic CMC Product Development Director
Strategic CMC Product Development Director

Scorpion Therapeutics • United States

On-site
USD 160,000 - 220,000