Barrington James
Executive Director, Product Development
Barrington James, San Francisco, California, United States, 94199
Key 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
Qualifications
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
Experience in small or emerging pharma environments strongly preferred
Deep technical expertise in oral peptide formulation and drug product development
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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
Qualifications
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
Experience in small or emerging pharma environments strongly preferred
Deep technical expertise in oral peptide formulation and drug product development
#J-18808-Ljbffr