Remote CMC Lead – Biopharma Formulation

BridgeBio; United States; On-site; USD 223,000 - 239,000; Full time

Benefits offered by this job

Hybrid work model

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Referral bonus for hired candidates

Job summary

BridgeBio is seeking a PhD-level CMC lead to provide strategic pharmaceutical development guidance to cross‑functional teams. The role focuses on robust formulation development and manufacturing processes to support QED product development and rapid regulatory registration.

The candidate will review programs at CROs, manage forecasts, and collaborate with the CMC team to ensure compliance with US/EU regulatory requirements. Remote work with travel expected; competitive benefits offered.

Qualifications

• PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharmaceutical industry experience in formulation development and Clinical Supply.
• Expertise in formulation in addition to knowledge of PK/PD principles, ADME concepts, and regulatory documentation and authorship.
• Knowledge of import/export sensitivities.
• Demonstrated ability to manage Clinical Supply, Formulation development and manufacture at CRO’s.
• In-depth knowledge and understanding of CMC Regulatory requirements for US and EU are required.

Responsibilities

• Provide strategic pharmaceutical development guidance as the CMC lead to cross functional project teams.
• Develop robust formulations and manufacturing processes to support development and rapid registration of QED products.
• Review development and manufacturing programs at CROs/external vendors to ensure compliance with agreed proposals, quality standards and timelines. Review external data.
• Manage drug forecasts and any associated transactions.
• Integrate and liaise effectively with CMC team.
• Provide formulation and Clinical supply expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).

Skills

CMC regulatory knowledge

Formulation development

Clinical supply management

Cross-functional collaboration

Regulatory documentation

Education

PhD or advanced degree in Chemistry or Pharmacy

Job description

BridgeBio is seeking a PhD-level CMC lead to provide strategic pharmaceutical development guidance to cross‑functional teams. The role focuses on robust formulation development and manufacturing processes to support QED product development and rapid regulatory registration.

The candidate will review programs at CROs, manage forecasts, and collaborate with the CMC team to ensure compliance with US/EU regulatory requirements. Remote work with travel expected; competitive benefits offered.