CMC Lead, Pharmaceutical Development (Remote)

BridgeBio Pharma; United States; Remote; USD 223,000 - 239,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program

Hybrid/Remote work

Medical, dental, vision premiums paid

HSA with employer contributions

Job summary

BridgeBio Pharma in the United States is seeking an Associate Director/Director of Pharmaceutical Development to lead CMC strategy for QED programs. You will provide strategic development guidance to cross‑functional teams and drive formulation development to enable rapid regulatory submission.

The role requires a PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharma experience, deep PK/PD knowledge, and CRO/CDMO oversight.

Qualifications

• PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharma industry experience in formulation development and Clinical Supply.
• Expertise in formulation and PK/PD, regulatory documentation and authorship.
• Knowledge of US/EU CMC regulatory requirements and CRO/CDMO oversight.

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 for compliance and data.
• Manage drug forecasts and any associated transactions.
• Integrate and liaise with the CMC team; support regulatory submissions (IB, IND, NDA).

Skills

Formulation development

Cross-functional collaboration

Regulatory documentation

PK/PD concepts

Clinical supply management

Education

PhD or advanced degree in Chemistry or Pharmacy

Job description

BridgeBio Pharma in the United States is seeking an Associate Director/Director of Pharmaceutical Development to lead CMC strategy for QED programs. You will provide strategic development guidance to cross‑functional teams and drive formulation development to enable rapid regulatory submission.

The role requires a PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharma experience, deep PK/PD knowledge, and CRO/CDMO oversight.