GondolaBio · 3 hours ago
Principal Scientist / AD CMC Drug Substance
Palo Alto, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$185K/yr - $210K/yr
5+ 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, focusing on process development and ensuring supply chain reliability and efficiency.
BiotechnologyManufacturingPharmaceutical
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
Qualification
Required
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
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
Benefits
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
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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