Barrington James · 3 hours ago
Executive Director, Product Development
San Francisco Bay Area
Full-time
Onsite
Director/Executive
15+ years expBarrington James is partnered with a growing pharmaceutical organization in the San Francisco Bay Area seeking an Executive Director to lead CMC strategy and execution for a portfolio of oral peptide drug products. This role provides end-to-end leadership across formulation development, process development, scale-up, and clinical supply for oral solid dosage forms, driving the transition from early development through commercialization.
Health CareRecruiting
Hiring Manager
Brandon Schelkle
Responsibilities
Define and execute CMC strategy for oral peptide drug products from early development through commercial readiness
Lead formulation and process development for oral solid dosage forms with a focus on stability, bioavailability, and manufacturability
Establish scalable development processes and systems to support portfolio growth
Provide hands-on technical oversight of process scale-up, technology transfer, and validation activities at CDMO partners
Partner closely with Regulatory, Quality, and Supply Chain to support progression through Phase 1–3 and commercialization
Author, review, and contribute to CMC sections of global regulatory submissions (IND, NDA/MAA)
Serve as a scientific and operational liaison across internal teams and external partners
Build, mentor, and lead high-performing technical teams in a fast-paced development environment
Qualification
Required
Ph.D. or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline
15+ years of pharmaceutical development experience with strong expertise in oral solid dosage formulation, including peptide-based therapeutics
Demonstrated leadership of CMC programs across the full development lifecycle, including late-stage and commercial launch
Extensive experience managing CDMO relationships and technology transfer activities
Hands-on knowledge of oral peptide delivery approaches, solid dosage engineering, and enabling formulation technologies
Proven success supporting Phase 3 and commercialization with submission-ready CMC documentation
Strong working knowledge of cGMP, ICH guidelines, and Quality by Design principles
Deep technical expertise in oral peptide formulation and drug product development
Preferred
Experience in small or emerging pharma environments strongly preferred
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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