Sr. Mgr/Assoc Dir, Commercial Manufacturing Operations
BridgeBio Pharma · 1800 Owens
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Role summary
BridgeBio seeks an Associate Director or Senior Manager to serve as the primary technical and operational lead for drug product manufacturing oversight at contract manufacturers for the Ecaleret program. The role requires coordinating with cross-functional teams to manage commercial manufacturing, process transfers, quality events, and regulatory compliance for small-molecule solid-oral-dose products.
What they're looking for
- Technical background in formulation or chemical engineering for small-molecule tablet manufacturing
- Experience with commercial-scale solid-oral-dose drug product manufacturing processes and equipment
- Knowledge of pharmaceutical CMC procedures, batch documentation, and regulatory requirements
- Strong project management and cross-functional collaboration skills
- Experience leading technical transfer, process validation, and quality investigations
- Ability to manage vendor relationships and coordinate complex interdisciplinary activities
What you'll be doing
- Oversee day-to-day manufacturing activities at contract manufacturers for small-molecule drug products
- Lead technical transfers, process validation, and document development for manufacturing operations
- Manage investigations of deviations and complaints, establish root causes and corrective actions
- Conduct meetings with CMOs, track action items, and ensure on-time batch delivery per supply plans
- Drive process improvement initiatives and resolve manufacturing issues across suppliers
Privacy & handoff
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