Associate Director, CMC Project Management

Posted 4 Days Ago
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South San Francisco, CA, USA
Hybrid
194K-237K Annually
Expert/Leader
Biotech
The Role
Leads end-to-end CMC project management across drug development programs, coordinating cross-functional teams, CMOs, regulatory activities, risk management, governance, timelines, budgets, and stakeholder communications. The role supports CMC planning and execution from early development through commercialization while improving project management processes and enabling regulatory and manufacturing milestones.
Summary Generated by Built In
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. 

As an Associate Director, we also expect our leaders to demonstrate the following Leadership Competencies:

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 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, and 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.


#LI-Hybrid

Skills Required

  • Bachelor's degree in life sciences, scientific, technical, engineering, or business discipline, or equivalent relevant experience
  • At least 10 years of total professional experience
  • At least 5 years of project management experience within the pharmaceutical, biotechnology, or medical device industry
  • At least 3 years managing cross-functional teams in a matrixed organization
  • Experience driving complex programs to completion in fast-paced environments
  • Working knowledge of CMC and drug development functions, including 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 or commercialization, including clinical development processes
  • Familiarity with GMP/GxP-regulated environments and quality management systems
  • Proficiency with project management and collaboration platforms such as Smartsheet, Microsoft Project, SharePoint, and Microsoft Office Suite
  • Strong organizational, prioritization, and time-management skills
  • Excellent verbal and written communication skills
  • Ability to build relationships and influence outcomes across teams without formal authority
  • Ability to work independently and collaboratively
  • Authorization to work in the United States
  • Advanced degree
  • Experience with late-stage or commercial programs
  • Experience with small molecule modalities
  • PMP certification
  • Prior exposure to startup or growth-stage biotechnology settings

Maze Therapeutics Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Maze Therapeutics and has not been reviewed or approved by Maze Therapeutics.

  • Healthcare Strength Benefits include employer-paid comprehensive medical, dental, and vision coverage for employees worldwide with additional support for dependents. Mental-health care is described as free, confidential, and unlimited, reinforcing the depth of coverage.
  • Leave & Time Off Breadth Time-off policies feature flexible vacation, generous PTO, and companywide breaks alongside standard holidays. Extended paid parental leave for birth or adoption further expands available time away from work.
  • Wellbeing & Lifestyle Benefits Total rewards are bolstered by a flexible lifestyle budget, a personalized remote-work budget, and tech perks. Additional offerings such as retreats and referral bonuses add to day-to-day wellbeing and engagement.

Maze Therapeutics Insights

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The Company
HQ: South San Francisco, CA
129 Employees
Year Founded: 2018

What We Do

Maze Therapeutics is translating novel genetic insights into lifesaving medicines, through an approach that integrates human genetics and functional genomics. Advances in these areas have enabled us to decode the mysteries of genetic modifiers in a range of severe diseases, which we aim to turn into medicines that mimic protective mutations. We have assembled a world-class team that we need to realize this vision, including creative scientific pioneers in genetics, experienced company builders, and biotech industry leaders.

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