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.
Responsibilities
- 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
Requirements
- 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
Manager/Sr. Manager, Analytical Development in san francisco at Unknown Company
This position is listed as contract and onsite.