GondolaBio · 13 hours ago
Principal Scientist / AD CMC Drug Substance
Palo Alto, CA
Full-time
Hybrid
Senior Level, Lead/Staff
7+ years expGondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. They are seeking an experienced process chemist to lead process chemistry activities for a late-phase small molecule, ensuring supply chain reliability and efficiency while collaborating with external partners for process validation and regulatory filings.
BiotechnologyManufacturingPharmaceutical
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
Qualification
Required
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
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
Benefits
Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
Flexible PTO
Access to learning and development resources to help you get in the best professional shape of your life
Rapid career advancement for strong performers
Commitment to Diversity, Equity & Inclusion
Company
GondolaBio
GondolaBio researches, develops and manufactures pharmaceutical products. It is a sub-organization of BridgeBio.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$300M2024-08-16Series Unknown· $300M
Leadership Team
J
James Li
President
Recent News
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