Senior CMC Project Lead — Cross-Functional Biotech Ops

BioSpace

South San Francisco (CA)

On-site

USD 194,000 - 237,000

Full time

3 days ago
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Benefits offered by this job

Annual bonus
Medical, dental, vision
401(k) match
PTO & holidays

Job summary

Maze Therapeutics seeks an Associate Director, CMC Project Management to drive cross‑functional planning and execution across our pipeline, coordinating development and manufacturing timelines with CMOs. You will align with CMC, Quality, and stakeholders to enable milestones and regulatory success, helping bring medicines to patients.

You will lead cross‑functional teams, manage risk, and coordinate governance, dashboards, and communications for senior leadership while supporting IND/IMPD

Qualifications

  • Bachelor's degree in life sciences or related field; advanced degree preferred.
  • Minimum 10 years total professional experience; 5+ years in PM within pharma/biotech.
  • ≥3 years in direct cross‑functional team leadership in a matrix environment.
  • Familiarity with GMP/GxP environments and quality systems; knowledge of CMC is a plus.

Responsibilities

  • Provide end-to-end CMC project management across drug development lifecycle.
  • Lead cross‑functional teams to plan and execute CMC activities.
  • Serve as primary point of contact with CMOs; manage meetings and actions.
  • Own risk management for programs; maintain risk registries and mitigate issues.
  • Support governance, decision-making, and regulatory filing prep with Regulatory CMC.
  • Create dashboards and status reports for stakeholders and leadership.

Skills

CMC PM
Cross-functional leadership
Communication
Independent work

Education

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

Tools

SmartSheet
Microsoft Project
SharePoint
MS Office Suite

Job description

Maze Therapeutics seeks an Associate Director, CMC Project Management to drive cross‑functional planning and execution across our pipeline, coordinating development and manufacturing timelines with CMOs. You will align with CMC, Quality, and stakeholders to enable milestones and regulatory success, helping bring medicines to patients.

You will lead cross‑functional teams, manage risk, and coordinate governance, dashboards, and communications for senior leadership while supporting IND/IMPD

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