Remote CMC Lead – Pharmaceutical Development Director

BridgeBio Inc.; Northern (KY); Hybrid; USD 223,000 - 239,000; Full time

Benefits offered by this job

Market-competitive compensation

401(k) with employer match

Employee stock purchase program (ESPP)

Comprehensive health benefits (medical

Hybrid/remote-friendly

Job summary

BridgeBio Inc. is seeking an Associate Director/Director of Pharmaceutical Development to lead CMC strategies for regenerative medicines, working remotely in the U.S. with travel expectations.

This role focuses on formulation development, clinical supply, and regulatory documentation to accelerate QED product registration. The successful candidate will hold a PhD in Chemistry or Pharmacy with 7+ years of industry experience, demonstrating deep CMC knowledge, PK/PD, and effective CRO/CDMO

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, ADME, and regulatory documentation.
• Knowledge of US/EU CMC regulatory requirements and import/export sensitivities.

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 proposals, quality standards and timelines.
• Manage drug forecasts and any associated transactions.
• Integrate with CMC team and provide formulation and clinical supply support for regulatory submissions.
• Work with CDMOs and CROs to ensure smooth execution and alignment with program goals.

Skills

CMC leadership

Regulatory knowledge

Cross-functional collaboration

Clinical supply management

Formulation development

Education

PhD in Chemistry or Pharmacy

Tools

CDMO management

Regulatory submission support

Job description

BridgeBio Inc. is seeking an Associate Director/Director of Pharmaceutical Development to lead CMC strategies for regenerative medicines, working remotely in the U.S. with travel expectations.

This role focuses on formulation development, clinical supply, and regulatory documentation to accelerate QED product registration. The successful candidate will hold a PhD in Chemistry or Pharmacy with 7+ years of industry experience, demonstrating deep CMC knowledge, PK/PD, and effective CRO/CDMO