Senior Principal Scientist, Drug Substance
Benefits
Unlimited PTO
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About Loyal:
- We are a clinical-stage veterinary medicine company developing the first FDA-approved drugs to extend canine lifespan.
- Loyal is a well-funded startup with a mission to help dogs live longer, healthier lives.
About the Role:
- This high-impact, externally-facing role leads drug substance process development and manufacturing from early development through commercialization.
- You will drive flawless execution across CDMO partners and serve as the internal subject matter expert for cross-functional decision-making.
Your Daily Work:
- Lead synthetic route assessment, impurity control, scale-up, technology transfer, and commercial manufacturing readiness at CDMOs.
- Manage drug substance supply continuity, including second source qualification and starting material risk strategy.
- Author regulatory submissions (VMF, INAD/NADA) and represent drug substance CMC in agency interactions.
About You:
- Ph.D. in Chemistry, Chemical Engineering, or related discipline with 12+ years of industry experience in drug substance process development.
- Deep knowledge of ICH Q7, Q8, Q9, Q10, Q11, Q6A, M7, and VICH guidelines for veterinary drug substances.
- Demonstrated ability to operate effectively in a dynamic startup environment with high autonomy and accountability.
Loyal
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. A well-funded startup with teams of scientists, veterinarians, engineers, operations, and creatives, we're committed to earning FDA approval for the first lifespan extension medicine for any species.