Sr. Director, Chemical Development

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Sr. Director, Chemical Development

Fully Remote Remote - San Francisco Bay Area

Gondola Bio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. Gondola Bio is an independent sister company to Bridge Bio, originally carved out in 2024 after securing $300M in private financing from external investors. Gondola Bio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

This position will report directly to the VP, CMC. This individual will assume a leadership role and actively engage in internal and external CMC activities for Gondola Bio's small molecule programs, including synthetic route selection and optimization, process development, impurity control, scale-up, technology transfer, and GMP drug substance manufacturing. As a subject matter expert, the Sr. Director of Chemical Development will lead internal teams and external CDMOs from early development through late-stage development and commercialization.

The successful candidate will bring strong scientific judgment, hands‑on execution, and dedication to advancing multiple programs in a fast‑paced small biotechnology environment, with experience interacting with regulatory authorities and supporting IND/NDA submissions.

• Identify, formulate, prioritize, and oversee chemical development strategies and activities to address complex technical and supply challenges.
• Collaborate with senior leadership, Research, Regulatory, Quality Assurance, Drug Product, Supply Chain, and Clinical Operations, and communicate chemical development risks and timeline impacts promptly.
• Lead CDMO process chemistry teams in advancing small molecule drug substances from candidate selection through NDA approval and launch.
• Lead route scouting, route selection, and process optimization to improve safety, robustness, yield, purity, scalability, cost, and raw material availability.
• Develop phase‑appropriate impurity control strategies, including understanding impurity formation, fate, purge, and carryover, as well as mutagenic impurity and nitrosamine risks.
• Lead process scale‑up, crystallization and isolation development, technology transfer, process characterization, validation, and GMP manufacturing activities.
• Design and execute detailed development and manufacturing work plans with CDMOs, providing active technical oversight and holding partners accountable for quality, timelines, budgets, and deliverables.
• Author and approve regulatory documents, development reports, manufacturing documentation, and responses to health authority questions, and participate in regulatory interactions.
• Review and approve protocols, reports, batch records, deviations, investigations, change controls, and corrective and preventive actions.
• Develop budgets, timelines, and resource plans, and manage and mentor internal scientists, consultants, and external technical teams while fostering a culture of urgency, ownership, and collaboration.

• Degree in organic chemistry, process chemistry, chemical engineering, or a related discipline. PhD with 15+ years of relevant pharmaceutical or biotechnology industry experience preferred.
• Extensive experience in small molecule synthetic route development, process chemistry, scale‑up, technology transfer, and GMP drug substance manufacturing.
• Track record of leading programs from early development through late‑stage development, registration, and launch.
• Deep expertise in route optimization, reaction and workup design, crystallization, isolation, drying, and process robustness.
• Strong experience developing impurity control strategies and understanding impurity formation, fate, purge, and regulatory qualification.
• Experience defining regulatory starting materials and controlling raw materials, intermediates, mutagenic impurities, elemental impurities, residual solvents, and nitrosamine risks.
• Experience with process characterization, validation, commercial readiness, and preparation of CMC regulatory…