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About the Role
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.
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 meeting discussions with CMOs and follow up on action items.
- Own risk management for assigned programs, including establishing risk registries, identifying and mitigating risks, and escalating issues.
- 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.
- Facilitate governance and decision-making by preparing proposals, analyses, and recommendations for senior leadership review.
- Contribute to the planning and preparation of regulatory filings in close partnership with Regulatory CMC and other functional teams.
- Drive clear, consistent communication through dashboards, status reports, and meeting operations for stakeholders.
- Cultivate strong working relationships across functions and with external partners.
- Champion continuous improvement of project management processes, tools, and governance frameworks.
- Support program-level budget tracking and financial forecasting.
- Communicate the reasoning behind decisions to appropriate stakeholders.
- Promote open communication with internal and external stakeholders.
- Foster healthy and respectful debate.
- Create opportunities for team members to connect with others outside the team.
- Manage conflict effectively between teams.
- Openly value thoughts, opinions and contributions of employees.
- Exercise astute judgement to make decisions with only the necessary amount of data.
- Support team members in creating their own resolutions to challenges and problems.
- Work with others to reinforce process compliance, what good looks like, and risk mitigation.
- Articulate what good looks like throughout Maze.
- Pursue development activities for continuous improvement of self and team.
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.
Skills
- CMC project management
- Cross-functional team leadership
- Risk management
- Regulatory filings
- Communication
- Collaboration
- Process improvement
- Budget tracking
- Financial forecasting
- Smart-sheet
- Microsoft Project
- SharePoint
- Microsoft Office Suite
Location
- San Francisco Bay Area
Work Type
- Hybrid
Experience Level
- Associate Director
- Minimum 10 years total professional experience
- Minimum 5 years in project management
- Minimum 3 years managing cross-functional teams
Education Level
- Bachelor's degree in life sciences, scientific, technical, engineering, or business discipline (or equivalent relevant experience)
- Advanced degree preferred
Salary/Compensations
- $193,500 - $236,500
- Eligible for an annual performance bonus
Benefits
- Competitive medical, dental, and vision insurance
- Mental health offerings
- Equity incentive plan
- 401(k) program with employer match
- Generous holiday and PTO policy
About the Company
- Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases.
- Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1‑mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease.
- We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.
- Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases.
- We are fostering a culture that encourages vision, initiative and the development of talent.
- Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work.
- While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
- Our Core Values: Further Together, Impact Obsessed, Stand True.