Associate Director, CMC Project Management South San Francisco, CA

BioSpace; South San Francisco (CA); On-site; USD 194,000 - 237,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Maze Therapeutics is seeking an Associate Director, CMC Project Management to drive cross-functional planning and execution across our pipeline programs. You will manage development and manufacturing timelines in collaboration with CMOs, partnering with CMC, Quality and internal stakeholders to enable milestones and regulatory success.

You will lead teams across Chemical Development, Pharmaceutical Development, CMC Analytical, QA, CMC Regulatory, and Clinical Supply Chain, owning risk management

Qualifications

• Bachelor's degree in life sciences, scientific, technical, engineering, or business discipline; advanced degree preferred.
• Minimum of 10 years total professional experience, with at least 5 years in project management in pharma/biotech/medical devices.
• At least 3 years directly managing cross-functional teams in a matrixed organization.
• Working knowledge of CMC and drug development functions across development lifecycle.
• Understanding of lifecycle through NDA/commercialization; GMP/GxP exposure; familiarity with quality systems.
• Proficiency with project management tools (Smart-sheet, MS Project, SharePoint, MS Office); PMP preferred.
• Strong organizational, prioritization, and communication skills; able to influence without formal authority.
• Ability to work independently and in startup/growth biotech settings; authorized to work in the U.S.

Responsibilities

• Provide end-to-end CMC project management across the drug development lifecycle.
• Lead cross-functional teams to plan and execute CMC activities aligned with goals.
• Facilitate meetings with CMOs and track action items.
• Own risk registries, mitigate risks, and escalate issues to protect timelines.
• Coordinate interdependencies across workstreams and govern CMC scope/status.
• Prepare proposals and analyses for senior leadership; resolve cross-team conflicts.
• Contribute to regulatory filings (IND, IMPD) in partnership with Regulatory CMC.
• Maintain dashboards, status reports, and meeting operations for stakeholders.
• Foster strong external partnerships and continuous improvement of PM processes.
• Support program-level budgeting and financial forecasting.

Skills

Cross-functional leadership

Program management

Communication

Risk management

Stakeholder management

Project governance

Organizational skills

Budget/forecasting

Education

Bachelor's degree in life sciences/engineering/business

Advanced degree preferred

Tools

Smart-sheet

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 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.

Leadership Competencies

Communication and InfluenceCommunicates the reasoning behind decisions to appropriate stakeholders

Promotes open communication with internal and external stakeholders

Fosters healthy and respectful debate

Teamwork and CollaborationCreates 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 ResultsExercises 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 SelfArticulate 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 biotech settings; must be authorized to work in the U.S.

About Maze Therapeutics

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.

Our People

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 – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $193,500 - $236,500. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.