Principal Scientist / AD CMC Drug Substance

About GondolaBio GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. Who You Are We are seeking an experienced and talented process chemist to lead process chemistry activities for a late-phase small molecule. The Process Chemist will lead process development activities for our oral small molecule drug substance as the program advances through clinical development. This role focuses on establishing a deep understanding of the synthetic process, developing a control strategy, and ensuring supply chain reliability and efficiency. The candidate will partner closely with CROs and CDMOs to execute process validation, design space studies, and preparation for commercial manufacture. Requirements Key Responsibilities Lead late-stage process development, scale-up, and validation activities for small molecule drug substance. Define and execute control strategies to ensure product quality and consistency. Conduct design space studies and process characterization to support regulatory filings. Oversee process validation campaigns at CDMOs, ensuring compliance with ICH and cGMP guidelines. Drive efficiency and robustness in the drug substance supply chain, from raw materials through API release. Anticipate and mitigate manufacturing risks related to scale, quality, and supply. Prepare and review CMC sections of regulatory filings (IND, NDA, MAA) related to process chemistry. Collaborate cross-functionally with analytical, formulation, regulatory, and quality teams to support integrated CMC strategy. Manage external CRO/CDMO partners to deliver on-time and on-budget. Preferred Education?&?Experience Ph.D. in Organic Chemistry, Process Chemistry, or related field; M.S. with extensive industry experience will be considered. 7+ years of pharmaceutical process development experience, with significant late-stage (Phase 2-3, validation, filing prep) exposure. Strong track record in drug substance process validation, control strategy development, and regulatory submissions. Experience conducting design space studies and risk-based process characterization. Understanding of supply chain management for small molecule drug substance. Proven ability to manage CROs/CDMOs for late-stage and commercial activities. Excellent communication, organizational, and problem-solving skills. Comfort working in a fast-paced, lean biotech setting. Thrives in a fast-paced, entrepreneurial environment with a hands-on approach Up to 20% travel may be required. Excellent communication skills with both technical and business stakeholders Strong organizational and problem-solving abilities in fast-paced environments No matter your role at GondolaBio, successful team members are Patient Champions, who put patients first and uphold strict ethical standards Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset Truth Seekers, who are detailed, rational, and humble problem solvers Individuals Who Inspire Excellence in themselves and those around them High-quality executors, who execute against goals and milestones with quality, precision, and speed 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 A place where you own the vision for 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 Commitment to Diversity, Equity & Inclusion The base pay range for this position is $185,000 to $ 210,000 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.

Created: 2026-03-04