Principal Scientist, CMC Analytical at loyalhealth

, , United States -

Full Time

Start Date

Immediate

Expiry Date

13 Oct, 26

Salary

190000.0

Posted On

15 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Development, Method Validation, CMC Analytical, Oral Solid Dosage, HPLC/UPLC, Dissolution Testing, GC, Karl Fischer, Regulatory Authoring, CDMO Management, cGMP, ICH/VICH Guidelines, OOS/OOT Investigations, Stability Testing, Impurity Profiling, Physicochemical Characterization

Industry

technology;Information and Internet

Description

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 We're seeking an experienced Principal Scientist, CMC Analytical to serve as the 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 Head of Quality Control/Analytical Development Your daily work will include: 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, building analytical capability across the team. About you: Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or a related field. 10+ years in QC laboratory operations and/or analytical method development with substantial hands-on experience in small-molecule oral solid dosage products. Sponsor-side pharma experience strongly preferred; animal health/veterinary experience a plus. Deep and broad knowledge of analytical chemistry in support of small molecule drug substance and drug product analytical development and quality control, including release and stability method development, raw material control, in-process control, and characterization . Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired. Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations. Proven track record of QC data interpretation and support of regulatory filings. Creative and thoughtful approach to problem solving technical issues. Ability to quickly learn new concepts and processes Adaptability, creativity and high-performer in risk-assessment and strategic thinking Willing to work and comfortable in a fast-paced startup environment with a dynamic team Clear and concise communication skills Salary Range: $150,000 - $190,000 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.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Lead the analytical development and quality control strategy for oral solid dosage programs, overseeing method lifecycle management and regulatory submissions. Act as the primary technical point of contact for CDMOs and serve as the final scientific authority for OOS and atypical result investigations.