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