Remote Associate Director, Process Chemistry & CDMO

BridgeBio Inc.; United States; A distancia; USD 177.000 - 205.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid/Remote work options

Market-competitive pay

Descripción de la vacante

BridgeBio Inc. seeks an Associate Director, Process Chemistry to lead drug substance development with external CDMOs and internal CMC teams. You will drive late-stage development, scale-up, and regulatory content for INDs/NDAs, ensuring on-time delivery and robust technical solutions.

This U.S.-based remote role requires a PhD in Organic Chemistry and 7+ years of industry experience. The position offers market-competitive pay, strong benefits, and opportunities for leadership across

Formación

• PhD in Organic Chemistry with industry experience in process chemistry.
• Experience leading route scouting, process development, scale-up, DOE, process validation, and CMC strategies for small molecule drug substances.
• Experience authoring regulatory documents (INDs, NDAs, MAAs, CBE30, Type II submissions).

Responsabilidades

• Oversee CDMOs for DS process chemistry activities with focus on late stage and validation.
• Author and manage RFPs to initiate work at CDMOs.
• Support DS content for CMC Regulatory for US and ROA; focus on late-stage development and applications.
• Support QA audits at CDMOs; act as SME as needed.
• Interface with other CMC team members (Analytical Chemistry, Formulation Development, QA, Supply Chain).
• Communicate Process Chemistry findings clearly in verbal and visual formats.

Conocimientos

Process chemistry

CDMO management

Regulatory documentation

Technical communication

Educación

PhD in Organic Chemistry

Purdue University (degree origin)

Descripción del empleo

BridgeBio Inc. seeks an Associate Director, Process Chemistry to lead drug substance development with external CDMOs and internal CMC teams. You will drive late-stage development, scale-up, and regulatory content for INDs/NDAs, ensuring on-time delivery and robust technical solutions.

This U.S.-based remote role requires a PhD in Organic Chemistry and 7+ years of industry experience. The position offers market-competitive pay, strong benefits, and opportunities for leadership across