Job Description
The Opportunity 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. The Impact You’ll Have Lead small molecule drug product formulation, process development, and manufacturing activities with external CDMOs. Ensure drug products meet quality, cost, time, safety, and operational goals. Evaluate CDMO capabilities and recommend approaches for development and manufacturing. Drive formulation, process development, scaleup, and tech transfer from initiation through regulatory approval. Shape and optimize CMC strategy, project plans, and execution. Monitor daily CMC activities, resolve challenges, and ensure cGMP compliance. Ensure CDMO processes meet needs across formulation development, tox studies, clinical trials, and commercial launch. Assess and implement new methods, tools, and technologies that elevate program success. Analyze scientific data, review batch documentation, and contribute to regulatory filings (IND/IMPD/CTA/NDA). Review and approve master and executed batch records; lead process improvements and drive solutions. Lead technical investigations, identify root causes, and implement corrective actions for deviations. Collaborate effectively across teams with integrity, impact, and a values-driven mindset. Represent Tech Ops and CMC in cross-functional settings. As a Senior Director , we also expect you to demonstrate the following Leadership Competencies: 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. What We’re Looking For PhD/MS/BS in Pharmacy, Pharmaceutics, Chemical Engineering, or related field. 15+ years of experience in Drug Product CMC development and manufacturing. Deep expertise in small molecule Drug Product CMC from preclinical through commercial stages. Experience leading Drug Product functions in biotech/pharma across multiple programs. Strong knowledge of GMP and ICH guidelines; experience authoring regulatory submissions is a plus. Direct manufacturing experience preferred. Proven success in tech transfer and scaleup. Ability to strategically and pragmatically partner with CDMOs to optimize quality and operations. Handson formulation development experience and the ability to share knowledge with external partners. Strong attention to detail and a talent for building robust Drug Product processes. Comfort navigating fast-paced, evolving startup environments. A self-starter mindset with strong leadership, communication, and decision-making skills. Willingness to travel as needed to support CMC goals with external partners. This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week About Maze Therapeutics 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