Senior Director, Pharmaceutical DevelopmentSouth San Francisco, CA
BioSpace, South San Francisco, CA, United States
Overview
The Senior Director of Pharmaceutical Development leads all small molecule drug product activities and serves 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 analyze process and analytical data to resolve key challenges and advise on the best path forward. This role requires strong cGMP expertise, supports regulatory submissions, and collaborates across research, development, and technical operations. You will coach teams for excellence, foster intellectual curiosity, and champion inclusive, impactful leadership. This role follows a hybrid schedule with an onsite expectation at our South San Francisco headquarters at least three days per week. This position reports to the Vice President, Technical Operations. Responsibilities
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. 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 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. Hands-on 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.
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The Senior Director of Pharmaceutical Development leads all small molecule drug product activities and serves 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 analyze process and analytical data to resolve key challenges and advise on the best path forward. This role requires strong cGMP expertise, supports regulatory submissions, and collaborates across research, development, and technical operations. You will coach teams for excellence, foster intellectual curiosity, and champion inclusive, impactful leadership. This role follows a hybrid schedule with an onsite expectation at our South San Francisco headquarters at least three days per week. This position reports to the Vice President, Technical Operations. Responsibilities
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. 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 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. Hands-on 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.
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