Position Overview 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 GondolaBio'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.
Responsibilities: - 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.
Requirements
Qualifications: - 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 submissions is highly desired.
- Knowledge of cGMP, ICH guidance, quality-by-design principles, and regulatory requirements in multiple regions.
- Demonstrated success working in a small biotechnology company and thriving in a fast-paced environment with evolving priorities and high individual accountability.
- Excellent organizational skills with accurate project budgeting, timeline management, and the ability to manage multiple programs simultaneously.
- Independent and team-oriented, with strong domestic and international CDMO selection, governance, technical oversight, and performance management experience.
- Strong communication, mentoring, leadership, problem-solving, and presentation abilities, with a hands-on and highly dedicated working style.
- Able to participate in early morning and/or late evening teleconferences with CDMOs and team members in other geographies, and willing to travel up to 20% of the time.
What We Offer - Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
- An unyielding commitment to always putting patients first.
- A decentralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science.
- A place where you own the vision - both for your program and your own career path.
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game.
- Access to learning and development resources to help you get in the best professional shape of your life.
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).
- Flexible PTO.
- Rapid career advancement for strong performers.
- Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time.
- Commitment to Diversity, Equity & Inclusion.
Compensation The base pay range for this position is $260,000 to $285,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.
