Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory and immunology diseases. Backed by General Catalyst.
About the role
As Principal Scientist/Associate Director, Process Chemistry, you'll have primary oversight of drug substance process development for your assigned programs. Working in close partnership with Medicinal Chemistry, you'll set the process development strategy from early route design through clinical supply and lead its execution through a network of external CDMO partners. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Ph.D. in chemistry with 8+ years of relevant pharmaceutical experience in process chemistry, or M.S. in chemistry with 15+ years of relevant pharmaceutical experience in process chemistry
- Demonstrated track record of setting and leading phase-appropriate route design, process development, specification setting, and control strategy development for API
- Experience with statistical design of experiments (DoE) and quality by design (QbD) principles
- In-depth knowledge of ICH guidelines (e.g., Q7, Q8–Q11, M7) and their application to drug substance development
- Proven experience leading drug substance development in a virtual model across multiple external CDMOs, including CDMO selection, technical oversight, and budget management
- Strong understanding of GMP requirements for early phase drug development
More about this role
As Principal Scientist/Associate Director, Process Chemistry, you'll have primary oversight of drug substance process development for your assigned programs. Working in close partnership with Medicinal Chemistry, you'll set the process development strategy from early route design through clinical supply and lead its execution through a network of external CDMO partners. You'll represent Process Chemistry on cross-functional program teams alongside CMC, Regulatory, Quality, and Clinical Supply, as Odyssey's pipeline advances from preclinical into clinical development.
- Hold primary oversight and accountability for drug substance process development on assigned programs, serving as the Process Chemistry lead and drug substance representative on cross-functional program and CMC teams
- Set process development strategy in collaboration with Medicinal Chemistry, providing early input on route selection, scalability, cost of goods, and developability during lead optimization and candidate selection, and ensuring a smooth transition of chemistry from discovery to development
- Define phase-appropriate drug substance development plans from preclinical through clinical stages, including...
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