Associate Director, CMC Project Management

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

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

The Position

Join Maze Therapeutics as our Associate Director, CMC Project Management. In this highly visible role within Technical Operations, you will drive cross-functional planning and execution across our pipeline programs while managing development and manufacturing timelines in collaboration with our CMOs. Reporting to the VP, Technical Operations, you will partner closely with CMC, Quality, and key internal stakeholders to enable program milestones, support regulatory success, and ultimately help bring potential medicines to patients.

The Impact You'll Have

• Provide end-to-end CMC project management support across the drug development lifecycle.
• Lead cross-functional teams (Chemical Development, Pharmaceutical Develop ment , CMC Analytical, QA, CMC Regulatory, and Clinical Supply Chain) to plan and execute CMC activities aligned with corporate goals .
• Serve as the point of contact to facilitate the meeting discussions with the CMOs and follow up on the action items .
• Own risk management for assigned programs - establishing risk registries, identifying and mitigating risks, and escalating issues before they impact timelines or objectives .
• Serve as the primary CMC project management point of contact to collaborate with the Program Management team, maintaining full command of CMC scope, status, and key risks while coordinating interdependencies across workstreams.
• Facilitate governance and decision-making by preparing proposals, analyses, and recommendations for senior leadership review, and resolving cross-team conflicts that could impede progress.
• Contribute to the planning and preparation of regulatory filings (e.g., IND, IMPD, etc.) in close partnership with Regulatory CMC and other functional teams.
• Drive clear, consistent communication through dashboards, status reports, and meeting operations (agendas, minutes, action-item follow-up) for stakeholders ranging from project teams to senior leadership.
• Cultivate strong working relationships across functions and with external partners to foster a collaborative, high-performing team environment and enable timely issue resolution.
• Champion continuous improvement of project management processes, tools, and governance frameworks, and support program-level budget tracking and financial forecasting.

Leadership Competencies

Communication and Influence

• Communicates the reasoning behind decisions to appropriate stakeholders
• Promotes open communication with internal and external stakeholders
• Fosters healthy and respectful debate

Teamwork and Collaboration

• Creates opportunities for team members to connect with others outside the team
• Manages conflict effectively between teams
• Openly values thoughts, opinions and contributions of employees

Execution and Results

• Exercises astute judgement to make decisions with only the necessary amount of data
• Supports team members in creating their own resolutions to challenges and problems
• Works with others to reinforce process compliance, what good looks like, and risk mitigation

Develop Others and Self

• Articulate what good looks like throughout Maze
• Pursues development activities for continuous improvement of self and team

What We're Looking For

Bachelor's degree in life sciences, scientific, technical, engineering, or business discipline required (or equivalent relevant experience); advanced degree preferred.

Minimum of 10 years total professional experience, including at least 5 years in project management within the pharmaceutical, biotechnology, or medical device industry.

• At least 3 years directly managing cross-functional teams in a matrixed organization, with demonstrated success driving complex programs to completion in fast-paced environments.
• Working knowledge of CMC and drug development functions such as process development, analytical development, formulation, manufacturing, quality systems, supply chain, packaging, and regulatory CMC requirements.
• Understanding of the drug development lifecycle from Pre-IND through NDA/commercialization, including clinical development processes; experience with late-stage or commercial programs is a plus.
• Familiarity with GMP/GxP-regulated environments and quality management systems, ideally within small molecule modalities.
• Proficiency with project management and collaboration platforms (e.g., Smart-sheet, Microsoft Project, SharePoint, Microsoft Office Suite); PMP certification preferred but not required.
• Strong organizational, prioritization, and time-management skills, with the ability to adapt to shifting priorities and manage multiple projects simultaneously.
• Excellent verbal and written communication skills, with the ability to build effective relationships and influence outcomes across teams without formal authority.
• Ability to work both independently and collaboratively, ideally with prior exposure to start-up or growth-stage