Senior Director, CMC Analytical

Join us at Maze Therapeutics as our Senior Director, CMC Analytical. In this highly visible leadership role within Technical Operations, you will own the analytical strategy for our early‑phase small molecule programs—setting the direction, building fit‑for‑phase plans, and ensuring execution with internal and external partners. 

You’ll lead analytical method development, validation, and transfer; establish product specifications; and oversee QC testing at CMOs and third‑party labs. Reporting to the VP, Technical Operations, you will partner closely across CMC, Quality, and key internal stakeholders to enable program milestones and support regulatory success, ultimately helping bring potential medicines to patients. 

• Develop and execute a forward-thinking analytical strategy aligned to CMC plans, program phase, and company priorities.  
• Define fit-for-phase specifications for drug substance (DS) and drug product (DP) manufacturing to enable clinical manufacturing and regulatory filings.  
• Oversee a range of analytical activities at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and qualification and maintenance of reference standards. 
• Own Maze approval of key analytical documents such as methods, validation protocols/reports, stability protocols/reports, specifications, change controls, and deviations/investigations. 
• Evaluate and select CMOs and analytical vendors by assessing capability, quality systems, and execution track record. 
• Manage external method development and stability studies and coordinate internal analytical lab work, ensuring alignment with DS/ DP development needs and timelines.  
• Partner with Quality Assurance (QA) to establish and improve SOPs and analytical workflows that promote efficiency, consistency, and compliance. 
• Author and review CMC sections of regulatory submissions, ensuring analytical content is accurate, complete, and inspection-ready.  
• Foster strong communication, decision-making, and alignment across the CMC team and internal stakeholders.  

As a Senior Director, we also expect you to demonstrate the following Leadership Competencies: 

Communication and Influence

• • Role models clear communication and open two-way conversations. 
  • Reinforces an environment where people feel heard and their opinions are valued. 
  • Inspires followership despite differing initial opinions. 

Teamwork and Collaboration 

• • Champions collaborations and connections across Maze. 
  • Establishes team norms and expectations. 
  • Seeks opportunities to spotlight team and individual contributions in public forums. 

Execution and Results 

• • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success. 
  • Coaches others on resource management and work distribution/delegation. 
  • Aligns work to Maze’s strategy, mission, and vision. 

Develop Others and Self 

• • Develops staff capabilities to handle delegation of responsibilities. 
  • Encourages staff to develop and execute personal stretch goals. 
  • Identifies and recommends ways to increase inclusive leadership. 

• Advanced degree in Chemistry or related field; a PhD is preferred 
• 12+ years of experience in small molecule analytical work in the pharmaceutical industry 
• Effectively communicates across all levels and functions, with exceptional verbal and written skills  
• Thorough understanding of cGMPs, ISO, and ICH guidelines, and industry best practices 
• Demonstrated leadership abilities honed through previous roles, driving teams toward success 
• Understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles 
• Strong collaboration skills and a track record of building effective partnerships (internal and external) 
• Robust project management skills are a plus 
• Willingness to travel as needed to support external partners and CMC goals 

 This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week    

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

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 $257,000 - $314,000. 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.

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