Senior Director, Pharmaceutical Development at Maze Therapeutics

South San Francisco, CAFull-timeTechnical Operations & Supply ChainPosted about 1 month ago

About the Role

<h3>The Opportunity</h3> As Senior Director of Pharmaceutical Development, you lead all small molecule drug product activities and serve as a technical expert overseeing processes at CDMOs. You guide formulation and process development, manage scaleups, and proactively identify risks, gaps, and solutions across CMC. You’ll dig into process and analytical data to resolve key challenges and advise on the best path forward.  You bring strong cGMP expertise, support regulatory submissions, and collaborate across research, development, and technical operations. You coach teams for excellence, fuel intellectual curiosity, and champion inclusive, impactful leadership.  This position reports to Vice President, Technical Operations.  <h3>The Impact You’ll Have</h3> <ul> <li>Lead small molecule drug product formulation, process development, and manufacturing activities with external CDMOs. </li> <li>Ensure drug products meet quality, cost, time, safety, and operational goals. </li> <li>Evaluate CDMO capabilities and recommend approaches for development and manufacturing. </li> <li>Drive formulation, process development, scaleup, and tech transfer from initiation through regulatory approval. </li> <li>Shape and optimize CMC strategy, project plans, and execution. </li> <li>Monitor daily CMC activities, resolve challenges, and ensure cGMP compliance. </li> <li>Ensure CDMO processes meet needs across formulation development, tox studies, clinical trials, and commercial launch. </li> <li>Assess and implement new methods, tools, and technologies that elevate program success. </li> <li>Analyze scientific data, review batch documentation, and contribute to regulatory filings (IND/IMPD/CTA/NDA). </li> <li>Review and approve master and executed batch records; lead process improvements and drive solutions. </li> <li>Lead technical investigations, identify root causes, and implement corrective actions for deviations. </li> <li>Collaborate effectively across teams with integrity, impact, and a values-driven mindset. </li> <li>Represent Tech Ops and CMC in cross-functional settings. </li> </ul> As a Senior Director, we also expect you to demonstrate the following Leadership Competencies: Leadership Competencies <ul> <li>Communication and Influence <ul> <li>Role models clear communication and open two-way conversations. </li> <li>Reinforces an environment where people feel heard and their opinions are valued. </li> <li>Inspires followership despite differing initial opinions. </li> </ul> </li> </ul> <ul> <li>Teamwork and Collaboration <ul> <li>Champions collaborations and connections across Maze. </li> <li>Establishes team norms and expectations. </li> <li>Seeks opportunities to spotlight team and individual contributions in public forums. </li> </ul> </li> </ul> <ul> <li>Execution and Results <ul> <li>Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success. </li> <li>Coaches others on resource management and work distribution/delegation. </li> <li>Aligns work to Maze’s strategy, mission, and vision. </li> </ul> </li> </ul> <ul> <li>Develop Others and Self <ul> <li>Develops staff capabilities to handle delegation of responsibilities. </li> <li>Encourages staff to develop and execute personal stretch goals. </li> <li>Identifies and recommends ways to increase inclusive leadership. </li> </ul> </li> </ul> <h3>What We’re Looking For</h3> <ul> <li>PhD/MS/BS in Pharmacy, Pharmaceutics, Chemical Engineering, or related field. </li> <li>15+ years of experience in Drug Product CMC development and manufacturing. </li> <li>Deep expertise in small molecule Drug Product CMC from preclinical through commercial stages. </li> <li>Experience leading Drug Product functions in biotech/pharma across multiple programs. </li> <li>Strong knowledge of GMP and ICH guidelines; experience authoring regulatory submissions is a plus. </li> <li>Direct manufacturing experience preferred. </li> <li>Proven success in tech transfer and scaleup. </li> <li>Ability to strategically and pragmatically partner with CDMOs to optimize quality and operations. </li> <li>Handson formulation development experience and the ability to share knowledge with external partners. </li> <li>Strong attention to detail and a talent for building robust Drug Product processes. </li> <li>Comfort navigating fast-paced, evolving startup environments. </li> <li>A self-starter mindset with strong leadership, communication, and decision-making skills. </li> <li>Willingness to travel as needed to support CMC goals with external partners. </li> </ul> This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week  <h3>About Maze Therapeutics</h3> 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. <h3>Our People</h3> 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. <hr> The expected annual salary range for employees located in the San Francisco Bay Area is $257,000 - $315,000. 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.   #LI-Hybrid

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