Sr. Manager, Analytical Development
BridgeBio Pharma · 1800 Owens
CMCCompany career page
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Role summary
BridgeBio Pharma seeks a senior analytical development manager to oversee analytical development, quality control, and stability activities across contract manufacturing sites. The role involves method development, regulatory submissions, and cross-functional collaboration to advance clinical assets in rare disease therapeutics.
What they're looking for
- Expertise in analytical techniques across multiple therapeutic modalities
- Experience with test method development, transfer, and phase-appropriate validation
- Knowledge of ICH quality guidelines and regulatory requirements
- Proven stability program management with data analysis and trending capabilities
- Strong verbal and written communication skills
- Background in drug substance and drug product quality control
What you'll be doing
- Manage contract analytical development and quality control activities and timelines
- Author and review analytical method transfer, validation protocols, and reports
- Support batch release through data review, specification generation, and certificate maintenance
- Monitor stability protocols and programs; adjudicate CMC sections for regulatory filings
- Lead out-of-specification investigations and implement corrective actions with quality assurance
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.