Senior Associate Director, Commercial Manufacturing Ops

BridgeBio Inc.; San Francisco (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

BridgeBio Inc. is seeking a senior Key Account Manager for drug product manufacturing at CMOs for the Ecaleret program.

You will act as the technical and operational lead for commercial DP manufacturing, including tech transfer, batch disposition, and QA/CMC documentation, interfacing with DP Formulation/CMC, Analytical Operations, Supply Chain, QA/QC, and RA CMC. Preferably based in San Francisco or US-remote with periodic in-person collaboration; requires BS/MS in Life Sciences or Engineering

Qualifications

• BS/MS in Life Sciences or Engineering required.
• 5–7 years of experience in commercial bulk DP manufacturing.
• CMO management or manufacturing plant experience in commercial production.
• Experience with formulation development, process validation and tech transfer; working knowledge of analytical methods for small molecule DP.

Responsibilities

• Oversee day-to-day DP CMO activities for commercial small molecule solid-oral dose manufacturing and release of bulk DP.
• Lead teleconferences with CMO and suppliers; capture minutes, track actions, and create workflows for complex CMC procedures and processes.
• Review/approve documentation (MBRs, specs, methods) and changes; manage batch disposition.
• Oversee investigations of deviations and complaints with root-cause analysis and CAPA implementation.
• Collaborate with CMC/QA/QC/RA CMC and Supply Chain to develop and operate CMC procedures and production schedules.

Skills

CMO management

Commercial DP manufacturing

Formulation development

Process validation

Tech transfer

Project leadership

Regulatory knowledge (FDA/ICH)

Analytical methods (small molecule DP)

Education

BS/MS in Life Sciences or Engineering

Job description

BridgeBio Inc. is seeking a senior Key Account Manager for drug product manufacturing at CMOs for the Ecaleret program.

You will act as the technical and operational lead for commercial DP manufacturing, including tech transfer, batch disposition, and QA/CMC documentation, interfacing with DP Formulation/CMC, Analytical Operations, Supply Chain, QA/QC, and RA CMC. Preferably based in San Francisco or US-remote with periodic in-person collaboration; requires BS/MS in Life Sciences or Engineering