Associate Director, CMC Project Management

Maze Therapeutics•South San Francisco, CA

9h•$193,500 - $236,500•Hybrid

About 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.

Requirements

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 biotech settings; must be authorized to work in the U.S.

Nice To Haves

Advanced degree preferred.
Experience with late-stage or commercial programs is a plus.
PMP certification preferred but not required.
Prior exposure to start-up or growth-stage biotech settings.

Responsibilities

Provide end-to-end CMC project management support across the drug development lifecycle.
Lead cross-functional teams (Chemical Development, Pharmaceutical Development, 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.