Principal Scientist, CMC Analytical

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.

We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year.

Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.

We're seeking an experienced Principal Scientist, CMC Analytical to serve as the analytical lead/subject matter expert in analytical development for oral solid dosage products. This role provides advanced technical analysis of drug substance and drug product data across release testing, stability testing, and method lifecycle management, and translates findings into actionable insights that inform quality decisions and regulatory strategy. Success requires deep expertise in analytical method development and validation, strong data trending and interpretation skills, and demonstrated regulatory authoring experience.

Your work will ensure that robust, phase-appropriate analytical methods and data packages support product quality, regulatory compliance, and successful advancement of therapies from early development through commercialization.

You will be reporting to our Senior Director, Analytical Development

• Lead the analytical development and quality control strategy for one or more programs, setting the technical direction for method development, validation, and lifecycle management to ensure robust, phase-appropriate control of product quality.
• Partner with CDMO and contract laboratory partners as the primary technical point of contact, driving resolution of complex analytical or method-related issues and holding partners accountable to scientific and quality standards.
• Lead drug substance (API) analytical method development, qualification, and validation, including forced degradation, related substances/impurity profiling, and physicochemical characterization to support process understanding and specification setting.
• Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs, and personally lead the resolution of the most complex or ambiguous data issues.
• Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long‑term stability, and translate findings into program‑level risk assessments and recommendations for leadership.
• Serve as the technical lead and final scientific authority during OOS, OOT, and atypical result investigations, driving root cause determination and ensuring scientifically sound, defensible conclusions.
• Own preparation and technical accuracy of the analytical development and quality control data packages supporting regulatory submissions, and author the CMC analytical sections of regulatory documents (e.g., NADA/INAD filings, briefing documents, and responses to health authority questions), ensuring data and method documentation are complete, scientifically sound, and submission‑ready.
• Mentor and provide technical guidance to junior scientists and analysts,…