--- title: 'Principal Analytical QA Specialist, Drug Substance at Loyal' canonical: 'https://feeny.ai/job/principal-analytical-qa-specialist-drug-substance-loyal-united-states-hva9wqft24jn' type: 'job' last_seen: '2026-09-10' --- # Principal Analytical QA Specialist, Drug Substance at Loyal - **Company:** Loyal - **Location:** United States - **Work type:** remote - **Posted:** 2026-07-15 - **Last confirmed live:** 2026-09-10 - **Apply:** https://job-boards.greenhouse.io/loyal36/jobs/5358318008 ## Job 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](https://loyal.com/posts/100m-for-first-longevity-drug) 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 Analytical QA Specialist, Drug Substance to provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management activities supporting the development and commercialization of Loyal's veterinary pharmaceutical products. Operating within Loyal's fully outsourced manufacturing network, the position supports batch disposition of active pharmaceutical ingredient (API) / drug substance, drug product, packaging and labeling through review and approval of protocols, reports, analytical methods, and associated GMP documentation. The role works collaboratively with Technical Operations and Analytical Development / Quality Control to ensure that the manufacture and laboratory analysis of drug substance, drug product, packaging & labeling of finished drug product conforms with cGMPs, VICH and global regulatory requirements. This position also partners with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. ## Your daily work will include Manufacturing & Analytical Quality Oversight - Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase. - Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development. - Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. - Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.). Batch Release / Disposition & Quality Systems - Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions. - Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches are compliant with cGMP requirements. - Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. - Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process. Regulatory & Cross-Functional Support - Perform data integrity and compliance assessments including review against source documentation for regulatory submissions. - Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines. - Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly ## About you - B.S./M.S. degree in in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field) - Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles. - Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products - In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems. - Experience managing CDMOs and collaborating effectively across cross-functional teams. - Capable of working successfully in a team/matrix environment and independently, as required. - Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously. - Ability to convey both written and verbal information effectively and efficiently. - Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail. - Willingness to travel (10%). Core Competencies: - Strong technical judgment and problem-solving - Attention to detail and commitment to quality - Excellent written and verbal communication - Ability to influence cross-functional teams and external partners - Effective project and time management - Collaborative mindset with a continuous improvement focus Preferred Qualifications: - Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus. - Experience auditing suppliers, CDMOs, and CTLs. - Experience with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems. - Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products preferred. - Experience with international regulatory environments (EU, Canada, etc.) a plus Salary Range: $150,000 - $190,000 Loyal benefits - Full-coverage health insurance β€” medical, dental and vision β€” 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 πŸŽ‰ - Unlimited vacation and paid holidays - Paw-ternity leave β€” 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. ## About Loyal ## Company Overview - **One-liner**: Loyal is a clinical-stage veterinary medicine company developing the first FDA-approved drugs intended to extend the lifespan and healthspan of dogs. - **Entity Type**: Private (Series C) - **Headquarters**: San Francisco, California, United States - **Founded**: 2020 - **Founders**: Celine Halioua ## Core Business - **Primary industry**: Veterinary Medicine / Animal Health Biotechnology - **Target customers**: B2B (veterinary clinics) and B2C (dog owners) - **Mission**: To help dogs live longer, healthier lives by developing drugs that target the underlying processes of aging. ## Products & Services For each major offering: - **[LOY-002](https://loyal.com)**: A once-daily pill targeting age-associated metabolic dysfunction in senior dogs (ages 10+, 14+ lb). It is the lead drug program and has completed the second of three major requirements for FDA conditional approval. Designed to extend lifespan and maintain quality of life. - **[LOY-001](https://loyal.com)**: A drug program targeting age-associated metabolic dysfunction (currently in earlier stages of development). - **Loyal Learning Hub**: A free library of RACE-approved continuing education courses for veterinary teams to improve care for senior dogs. ## Market Standing - **Valuation/Market Cap**: Not disclosed - **Total Funding**: $238.0M across six rounds - Series C (2026-02-01): $100M [LinkedIn](https://www.linkedin.com/company/loyalfordogs) - Series B (2025-02-01): $22M - Series B (2024-03-01): $45M - Series A (2022-04-01): $13M - Series A (2021-09-01): $27M - **Key Metric**: Annual Revenue of $2.0M (pre-commercial stage) [LinkedIn](https://www.linkedin.com/company/loyalfordogs) - **Notable Investors/Partners**: 2 investors in Series B (2025), 3 investors in Series C (2026) [LinkedIn](https://www.linkedin.com/company/loyalfordogs) - **Growth Signals**: Headcount grew 53.3% year-over-year to 71 employees [LinkedIn](https://www.linkedin.com/company/loyalfordogs). Targeting commercial launch of LOY-002 in 2027. Completed 2/3 major FDA review sections for LOY-002 as of early 2026 [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008). ## Competitive Advantages - **First-to-market**: Pioneering the first FDA-approved lifespan extension drug for any species, creating a new category in veterinary prescription medicine. - **Regulatory moat**: Achieving FDA conditional approval for a longevity drug is an extremely difficult technical and regulatory pursuit, creating a significant barrier to entry. - **Targeting aging itself**: Unlike most veterinary drugs that treat specific diseases, Loyal targets the underlying drivers of aging to delay the onset of multiple age-related conditions. - **Strong clinical trial infrastructure**: 70 veterinary clinics enrolled in the STAY clinical trial, with over 1,317 dogs accepted [loyal.com](https://loyal.com). ## Strategic Focus - **Regulatory approval**: Completing the third and final FDA review section for LOY-002 and targeting submission in late 2026 [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008). - **Commercial launch preparation**: Scaling the company from ~70 to ~150 people, building a customer service organization, and leading product distribution platform buildout for prescription drug distribution, targeting a 2027 launch [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008). - **AI-leveraged efficiency**: Deploying AI tooling across operations, finance, recruiting, and customer service to scale leverage with the team [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008). - **Pipeline expansion**: Developing a portfolio of three drug programs (LOY-002, LOY-001, and others) targeting different aspects of aging. ## Why Work Here - **Mission-driven**: The company is deeply committed to helping dogs live longer, healthier lives β€” a compelling purpose for many job seekers. - **Culture**: Values include "Empathy and respect for all life," "Expertise without ego," "High agency, high humility," and "Lead with transparency and context" [loyal.com/careers](https://loyal.com/careers). - **Remote-first**: All open roles are listed as "Remote - US" [Greenhouse](https://job-boards.greenhouse.io/loyal36). - **Generous benefits** [loyal.com/careers](https://loyal.com/careers): - Full-coverage health insurance (medical, dental, vision) for you and dependents - $1,000 home office equipment stipend - $1,200/year learning budget - $250/month wellness budget (gym, cleaners, spa, food) - All 3-day weekends turned into 4-day weekends - Unlimited vacation and paid holidays - "Paw-ternity leave" β€” adopt a dog and get a day off - Annual company retreat at beautiful locations (recently: Tahoe, Cape Cod) - Competitive salary and equity options grant - **Leadership**: Founded and led by a first-gen female CEO, Celine Halioua. The company is an equal opportunity employer. - **Growth opportunity**: As a well-funded startup targeting a 2027 commercial launch, there is significant potential for career growth and impact. ## Sources 1. [loyal.com](https://loyal.com) 2. [loyal.com/careers](https://loyal.com/careers) 3. [LinkedIn - Loyal](https://www.linkedin.com/company/loyalfordogs) 4. [Greenhouse - Loyal Jobs](https://job-boards.greenhouse.io/loyal36) 5. [Greenhouse - COO Job Posting](https://job-boards.greenhouse.io/loyal36/jobs/5235415008) ## Other roles at Loyal - [Senior Statistician, Research & Development](https://feeny.ai/job/senior-statistician-research-development-loyal-united-states-0r3knng5j7zr) β€” United States - [Director, FP&A](https://feeny.ai/job/director-fp-a-loyal-united-states-nb572c2e9bfg) β€” United States - [Senior Associate Specialist, Regulatory Operations](https://feeny.ai/job/senior-associate-specialist-regulatory-operations-loyal-united-states-bd9kwj4pttpt) β€” United States - [Senior Principal Scientist, Drug Substance](https://feeny.ai/job/senior-principal-scientist-drug-substance-loyal-united-states-6fv71bjzb5w0) β€” United States - [Director, Regulatory Affairs - Clinical](https://feeny.ai/job/director-regulatory-affairs-clinical-loyal-united-states-1j9et5dxrqdn) β€” United States