CMC Program Lead – Biotech (Hybrid)

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 194,000 - 237,000; Full time

Job summary

Maze Therapeutics is seeking an Associate Director, CMC Project Management to lead cross-functional planning and execution across our evolving pipeline, coordinating with CMOs and internal stakeholders to meet development milestones.

You will own risk management and oversee CMC activities across development, QA, analytical, and regulatory functions, ensuring timely regulatory submissions and cross-team alignment in a fast-paced biotech setting.

Qualifications

• Bachelor's degree in life sciences or related field required (advanced degree preferred).
• Minimum of 10 years total professional experience, including at least 5 years in project management within pharma/biotech/medical device.
• At least 3 years directly managing cross-functional teams in a matrixed organization.

Responsibilities

• Provide end-to-end CMC project management support across the drug development lifecycle.
• Lead cross-functional teams to plan and execute CMC activities aligned with corporate goals.
• Serve as the point of contact to facilitate meetings with CMOs and follow up on actions.
• Own risk management for assigned programs with risk registries and escalation.
• Coordinate interdependencies across workstreams and maintain CMC scope and status.
• Prepare proposals, analyses, and recommendations for senior leadership review.
• Contribute to regulatory filings (IND, IMPD, etc.) with Regulatory CMC and other teams.
• Drive dashboards, status reports, and meeting operations for stakeholders.
• Foster collaboration across functions and external partners; support program budgeting and forecasting.

Skills

CMC project management

Cross-functional leadership

Regulatory filings experience

GxP knowledge

Stakeholder communication

Budget tracking

Education

Bachelor's degree in life sciences

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 lead cross-functional planning and execution across our evolving pipeline, coordinating with CMOs and internal stakeholders to meet development milestones.

You will own risk management and oversee CMC activities across development, QA, analytical, and regulatory functions, ensuring timely regulatory submissions and cross-team alignment in a fast-paced biotech setting.