Senior Principal Scientist, Drug Substance

Senior Principal Scientist, Drug Substance Remote - US About Loyal 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. About the role Loyal is seeking a Senior Principal Scientist, Drug Substance to serve as the technical leader for drug substance process development and manufacturing from early development through commercialization. This high-impact, externally-facing role will drive drug substance process development and manufacturing, and deliver flawless execution across CDMO partners while serving as the internal subject matter expert informing cross-functional decision-making and long-term development strategy across Loyal's growing pipeline. You will be reporting to our VP of Manufacturing Your daily work will include Lead end-to-end drug substance process development and manufacturing for small molecule APIs from synthetic route assessment and impurity control through scale-up, technology transfer, and commercial manufacturing readiness at CDMOs. Serve as the primary technical interface with drug substance CDMOs spanning partner selection, day-to-day oversight, troubleshooting, PAI preparation and performance management; ensure drug substance supply continuity, including second source qualification and starting material supply risk strategy, in support of clinical and commercial manufacturing. Lead RSM designation, ICH Q11 assessments, impurity fate and purge strategies and ICH M7 mutagenic impurity risk assessments; establish CQAs, CPPs, and ICH Q6A-aligned control strategies. Lead drug substance process validation from PPQ protocol development through batch execution and CPP/CQA verification; align PPQ timelines and batch disposition with drug product process validation and registration batch campaigns. Author, review, and approve drug substance CMC sections for regulatory submissions (VMF, INAD/NADA); represent drug substance CMC in agency interactions and ensure a technically integrated and consistent regulatory package. Partner with drug product development to translate drug substance CQAs into formulation design, excipient selection, container closure strategy and final dosage form decisions. Partner with analytical development to define method development, qualification, and validation strategy for drug substance release and stability testing. Partner with Quality to align drug substance specifications, batch disposition, and GMP compliance across CDMOs, and to support inspection and regulatory submission readiness. Manage drug substance post-approval change control strategy for manufacturing changes at CDMOs. About you Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related discipline. 12+ years of industry experience in drug substance process development and manufacturing, with demonstrated ownership from early development through regulatory submission and commercialization phase. Hands-on expertise in small molecule API process development, including synthetic process understanding, impurity profiling, ICH Q11 RSM assessment, and ICH M7 mutagenic impurity control. Proven experience selecting, managing, and technically overseeing CDMOs for small molecule drug substance development, scale-up, technology transfer and PPQ. Demonstrated experience authoring and defending drug substance CMC regulatory submissions (INAD/NADA, VMF or equivalent) and interacting with regulatory agencies on CMC questions. Deep knowledge of applicable regulatory frameworks: ICH Q7, Q8, Q9, Q10, Q11, Q6A, M7, and relevant VICH guidelines for veterinary drug substances. Demonstrated ability to operate effectively in a dynamic, fast-paced startup environment with a high degree of autonomy and accountability. Experience with large biomolecule drug substance development (peptides, proteins, or other biological entities) preferred but not required. Veterinary dosage form experience preferred but not required. Salary Range: $175,000 - $230,000 Loyal benefits Full-coverage health insurance — medical, dental and vision — for you and your dependents

• 1,000 home office equipment stipend
• 1,200/year learning budget for books, courses, etc.
• 250/month wellness budget for gym, cleaners, spa, food, etc.

All 3-day weekends are turned into 4-day weekends Unlimited vacation and paid holidays Paw-ternity leave — adopt a dog and get a day off with your new family member Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Moonshots, derisked methodically Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure. Opportunity is at the intersection We lean into combining disciplines, expertise, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat. High agency, high humility Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission. Lead with transparency and context We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions. Empathy and respect for all life Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously. Loyal