Barrington James · 2 weeks ago
Senior/Executive Director Product Development CMC
California, United States
Full-time
Hybrid
Director/Executive
10+ years expBarrington James is partnering with a fast-growing, clinical-stage biotech company focused on innovative therapies in metabolic and cardiometabolic diseases. They are seeking a Senior Director / Executive Director of Drug Product & Formulations (CMC) to lead drug product development from early formulation through Phase 3 and commercial launch.
Health CareRecruiting
Hiring Manager
Ryan Banton
Responsibilities
Lead the entire CMC lifecycle for oral solid dose and peptide drug products, spanning early development, clinical manufacturing, tech transfer, scale-up, and commercial introduction
Drive drug product and formulation strategy, ensuring alignment with regulatory requirements and company goals
Manage and oversee CDMO partners, ensuring high-quality, on-time delivery of clinical and commercial material
Provide technical leadership for formulation design, process development, scale-up, and troubleshooting
Support regulatory filings and preparation for Phase 3 and commercial submissions
Collaborate closely with cross-functional teams, including Analytical Development, Process Development, Regulatory, and Manufacturing
Qualification
Required
Lead the entire CMC lifecycle for oral solid dose and peptide drug products, spanning early development, clinical manufacturing, tech transfer, scale-up, and commercial introduction
Drive drug product and formulation strategy, ensuring alignment with regulatory requirements and company goals
Manage and oversee CDMO partners, ensuring high-quality, on-time delivery of clinical and commercial material
Provide technical leadership for formulation design, process development, scale-up, and troubleshooting
Support regulatory filings and preparation for Phase 3 and commercial submissions
Collaborate closely with cross-functional teams, including Analytical Development, Process Development, Regulatory, and Manufacturing
Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field; PhD preferred but not mandatory
10+ years of relevant industry experience across drug product development, formulation, and manufacturing, with increasing leadership responsibility
Extensive experience with peptides and oral solid dose formulations
Demonstrated track record leading late-stage (Phase 3) and commercial programs
Direct experience managing large CDMOs and tech transfer projects
Company
Barrington James
Barrington James has a true global reach, with its international HQ in London-Gatwick, continental hubs in Singapore.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Orangewood Partners
2022-10-05Private Equity
Recent News
2022-10-14
2022-10-06
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