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.

Key Responsibilities:

• Lead process development for the company’s oral small molecule drug substance.
• Design, evaluate, and optimize synthetic routes to improve yield, robustness, scalability, and sustainability.
• Perform route scouting and select optimal synthetic strategies for scale-up.
• Oversee process chemistry activities at CROs/CDMOs, including tech transfer, process optimization, and GMP manufacturing.
• Identify and mitigate potential scale-up risks (safety, quality, regulatory).
• Collaborate cross-functionally with internal teams (CMC, formulation, regulatory, program management).
• Prepare process development reports and regulatory documentation to support IND/clinical filings.
• Ensure alignment of drug substance process development with overall program timelines and milestones.

Preferred Education & Experience:

• Ph.D. in Organic Chemistry, Process Chemistry, or related discipline; M.S. with significant industry experience considered.
• 5 years of relevant experience in pharmaceutical or biotech process development.
• Strong background in synthetic organic chemistry, route design, and optimization.
• Demonstrated experience with drug substance scale-up and GMP manufacturing.
• Proven ability to manage CROs/CDMOs and drive external partnerships effectively.
• Excellent problem-solving, organizational, and communication skills.
• 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

Salary:

• 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.