Manager/Sr. Manager, Analytical Development

BridgeBio Pharma · 1800 Owens

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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

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Date posted29 days ago

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