Associate Director, CMO Manufacturing & Tech Transfer

BridgeBio Pharma; San Francisco (CA); Hybrid; USD 173,000 - 215,000; Full time

Benefits offered by this job

Hybrid work model

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Job summary

BridgeBio Pharma is seeking a Senior Key Account Manager for drug product manufacturing at CMOs supporting the Ecaleret program. You will act as the technical and operational lead for commercial DP manufacturing, including tech transfer, batch release, and documentation review, interfacing with DP Formulation/CMC, Analytical Operations, QA, and RA CMC.

The role requires 5–7 years in commercial DP manufacturing, CMO management experience, and familiarity with FDA/ICH guidelines.

Qualifications

• BS/MS in Life Sciences or Engineering required.
• 5–7 years in commercial bulk DP manufacturing and analytical activities.
• Experience with CMO management or manufacturing plant operations.
• Familiarity with FDA/ICH guidelines (21 CFR 210/211) and cGMP.
• Strong technical background in formulation/chemical engineering for small molecules.

Responsibilities

• Oversee day-to-day commercial DP CMOs for solid oral dose manufacturing.
• Coordinate tech transfer, process validation, and batch disposition.
• Review and approve MBRS, specs, methods; manage CAPA closures.
• Lead investigations into deviations and complaints with root-cause analysis.
• Collaborate with DP Formulation/CMC, QA/QC, RA CMC and Supply Chain.

Skills

Project leadership

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

BS/MS (Life Sciences or Engineering)

Job description

BridgeBio Pharma is seeking a Senior Key Account Manager for drug product manufacturing at CMOs supporting the Ecaleret program. You will act as the technical and operational lead for commercial DP manufacturing, including tech transfer, batch release, and documentation review, interfacing with DP Formulation/CMC, Analytical Operations, QA, and RA CMC.

The role requires 5–7 years in commercial DP manufacturing, CMO management experience, and familiarity with FDA/ICH guidelines.