Senior Director, Drug Substance (Small Molecule)
About The Position
Structure Therapeutics develops life‐changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Reporting to the SVP Tech Ops, the Senior Director, Drug Substance (Small Molecule) will be responsible for late-stage development, scale-up, validation, and commercial readiness of small-molecule drug substance. This leader will direct Late Stage, PPQ, and commercial launch activities and establish a robust technical and quality foundation for long-term product success. The role requires deep expertise in process chemistry, QbD, FMEA, and regulatory expectations, combined with extensive experience managing global CDMOs, CMOs, and CRO partners.
Requirements
- Ph.D. in Organic Chemistry, Process Chemistry, Chemical Engineering, or related field (or M.S. with significant experience).
- 12+ years experience in small-molecule development, scale-up, and manufacturing.
- Leadership through Late Stage phase, PPQ, and commercial launch.
- Strong track record managing CDMOs/CROs.
- Deep knowledge of QbD, FMEA, ICH Q7/Q8/Q9/Q10/Q11.
- Extensive regulatory writing and defense experience.
- Experience with post-approval changes and lifecycle management.
- Leadership in emerging biotech or virtual manufacturing models.
- Strong communication and strategic leadership skills.
- Ability to anticipate risks and drive proactive mitigation.
- Strength in negotiation, influence, and team leadership.
- Commitment to scientific excellence, compliance, and efficiency.
Responsibilities
- Lead strategic direction for drug substance development from late-phase clinical through commercialization.
- Develop technical roadmaps, risk mitigation strategies, and lifecycle management plans.
- Apply QbD principles to define design space, CPPs, CQAs, and control strategies.
- Lead FMEA activities and ensure risk assessments inform decisions.
- Drive optimization of synthetic routes, process robustness, impurity control strategies, and crystallization.
- Oversee preparation and execution of PPQ and validation activities at external sites.
- Ensure process characterization studies and tech transfer documentation are complete and compliant.
- Act as primary technical and strategic interface with CDMOs and CROs.
- Lead vendor selection, due diligence, and contract negotiations.
- Establish governance structures such as Joint Steering Committees and Technical Working Groups.
- Manage CDMO programs including timelines, budgets, and issue escalation.
- Conduct technical reviews, facility assessments, and ensure GMP compliance.
- Guide CROs supporting analytical work, impurity elucidation, and safety studies.
- Drive resolution of deviations, OOS/OOT, CAPAs, and process troubleshooting.
- Build strong collaborative relationships with global vendors.
- Author and review CMC documentation for global submissions.
- Prepare for and lead regulatory interactions with FDA and EMA.
- Ensure data packages for PPQ and control strategy meet regulatory expectations.
- Partner with Analytical, Drug Product, Quality, Supply Chain, and Regulatory teams.
- Contribute to CMC governance and technical forums.
- Mentor and develop process chemists, engineers, and CMC leaders.
Benefits
- medical, dental, and vision insurance
- 401k match
- unlimited PTO
- a number of paid holidays including winter shutdown
- annual performance incentive bonus
- new hire equity
- ongoing performance-based equity
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
