Senior Manager Analytical Operations
BridgeBio Pharma · Remote
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Role summary
BridgeBio Pharma seeks a Senior Manager to oversee analytical development and quality control operations for drug substances and products across contract manufacturing sites. The role involves managing method development, validation, and stability programs while collaborating with cross-functional teams and contributing to regulatory submissions. Experience with ICH guidelines, various analytical techniques, and CMC documentation is essential.
What they're looking for
- Expertise in analytical technique development across multiple drug modalities
- Experience with test method development, transfer, and phase-appropriate validation
- Knowledge of stability program management, data trending, and analysis
- Thorough understanding of ICH quality guidelines and regulatory requirements
- Strong verbal and written communication skills
- Hands-on experience in analytical development and quality control
What you'll be doing
- Manage contract drug substance and product analytical development and QC timelines
- Review and approve analytical method transfer, validation, and stability protocols
- Author and review CMC sections for US and international regulatory submissions
- Direct batch release activities including sampling plan review and specification management
- Lead out-of-specification and deviation investigations with root cause analysis
Privacy & handoff
This role links to BridgeBio Pharma's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.