Drug Product Manufacturing Lead — Senior Scientist/AD

BridgeBio Inc.; San Francisco (CA); Híbrido; USD 175.000 - 185.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program

Hybrid work model

Paid time off

Descripción de la vacante

BridgeBio Inc. is seeking a Senior Scientist/Associate Director for Drug Product Manufacturing in a hybrid San Francisco role.

You will oversee commercial drug product manufacturing at CMOs, coordinating with CMC, Supply Chain, QA, and regulatory teams while serving as a technical liaison between BridgeBio and CMOs. The role requires a BA/BS in a life sciences field, 8+ years in pharma, strong cGMP knowledge, and experience with quality oversight and on-floor support.

Formación

• BA/BS degree in Life Sciences, Engineering, or related field required.
• Minimum of eight (8) years of experience within the pharmaceutical industry required.
• Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.
• Experience with cGMP quality oversight and on floor production support required.
• Understanding of Quality Management Systems required.
• Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required.
• Ability to periodically travel (up to 30%)

Responsabilidades

• Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms).
• Perform activities related to batch review & release.
• Participate & provide input to root-cause analysis and CAPA plans.
• Participate in process confirmations, change controls, & quality oversight.
• Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results.
• Generate batch genealogy for commercial materials

Conocimientos

cGMP knowledge

CMC manufacturing

On-floor production support

Regulatory liaison

Educación

BA/BS Life Sciences or related

Descripción del empleo

BridgeBio Inc. is seeking a Senior Scientist/Associate Director for Drug Product Manufacturing in a hybrid San Francisco role.

You will oversee commercial drug product manufacturing at CMOs, coordinating with CMC, Supply Chain, QA, and regulatory teams while serving as a technical liaison between BridgeBio and CMOs. The role requires a BA/BS in a life sciences field, 8+ years in pharma, strong cGMP knowledge, and experience with quality oversight and on-floor support.