Loyal · 2 weeks ago
Principal Scientist, CMC Analytical
United States
Full-time
Remote
Lead/Staff
$150K/yr - $190K/yr
10+ years expLoyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. They are seeking an experienced Principal Scientist, CMC Analytical to lead analytical development and quality control strategies, ensuring robust methods support product quality and regulatory compliance.
BiotechnologyPetPharmaceuticalVeterinary
Responsibilities
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
Qualification
Required
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
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
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
Preferred
Sponsor-side pharma experience strongly preferred
Animal health/veterinary experience a plus
Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired
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 🐶
Company equity options grant for new hires
Company
Loyal
Loyal is a clinical-stage veterinary medicine company dedicated to extending the healthy lifespan of senior dogs.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$237.14MKey Investors
age1Collaborative Fund,Valor Equity PartnersBain Capital Ventures
2026-02-11Series C· $100M
2025-02-26Series B· $22M
2024-03-21Series B· $45M
Leadership Team
Celine Halioua
Founder & CEO
Recent News
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