Senior Director, Pharmaceutical Development
Maze Therapeutics
4 months ago
Remote friendly (South San Francisco, CA)
United States
Operations
The Opportunity
As Senior Director of Pharmaceutical Development, you lead 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 analyze process and analytical data to resolve key challenges and advise on the best path forward.
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 across teams with integrity and a values-driven mindset.
- Represent Tech Ops and CMC in cross-functional settings.
Qualifications
- 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 partner with CDMOs to optimize quality and operations.
- Hands-on formulation development experience and ability to share knowledge with external partners.
- Strong attention to detail and ability to build robust Drug Product processes.
- Comfort navigating fast-paced, evolving startup environments.
- Self-starter with strong leadership, communication, and decision-making skills.
- Willingness to travel as needed to support CMC goals with external partners.
Benefits
- Eligible for an annual performance bonus.
- Robust benefits package including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) with employer match, and generous holiday and PTO policy.
Hybrid schedule
- Onsite at South San Francisco headquarters at least three days per week.
As Senior Director of Pharmaceutical Development, you lead 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 analyze process and analytical data to resolve key challenges and advise on the best path forward.
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 across teams with integrity and a values-driven mindset.
- Represent Tech Ops and CMC in cross-functional settings.
Qualifications
- 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 partner with CDMOs to optimize quality and operations.
- Hands-on formulation development experience and ability to share knowledge with external partners.
- Strong attention to detail and ability to build robust Drug Product processes.
- Comfort navigating fast-paced, evolving startup environments.
- Self-starter with strong leadership, communication, and decision-making skills.
- Willingness to travel as needed to support CMC goals with external partners.
Benefits
- Eligible for an annual performance bonus.
- Robust benefits package including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) with employer match, and generous holiday and PTO policy.
Hybrid schedule
- Onsite at South San Francisco headquarters at least three days per week.