Principal Analytical QA Specialist, Drug Substance

5 hours, 18 minutes ago
Full-time
Lead
Quality Assurance and Testing
Loyal

Loyal

Loyal is a clinical-stage biotechnology company based in San Francisco, California, founded in 2020. The company is dedicated to developing prescription drugs aimed at extending the healthy lifespan and improving the quality of life for dogs. Loyal focuses on preventive care by addressing age-associated diseases and metabolic dysfunction in dogs, particularly large breeds. The company is led by CEO Celine Halioua and has raised over $116.81 million in funding, with ongoing efforts to secure FDA approvals through its Center for Veterinary Medicine. Loyal's drug development pipeline includes three main products targeting longevity and healthy aging in dogs. LOY-002 is designed for senior dogs and aims to correct metabolic dysfunction, while LOY-001 and LOY-003 focus on correcting IGF-1 and growth hormone overexpression in large dogs. The company is conducting a nationwide clinical study called STAY, enrolling 1,300 senior dogs across 70 veterinary clinics. Loyal emphasizes partnerships with veterinary professionals for the administration of its products and conducts research involving DNA sequencing from canine saliva samples.

research
201-500
Founded 2020
$238M raised

Description

  • Oversee quality assurance for drug substance and drug product manufacturing and testing across clinical development and commercialization.
  • Support batch disposition by reviewing executed documentation, raw data, quality events, and product disposition decisions.
  • Review and approve validation protocols, analytical methods, raw data, reports, batch records, stability documentation, and other GMP records.
  • Provide oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs.
  • Support establishment of specifications, stability-indicating methods, and control strategies aligned with regulatory expectations.
  • Lead or support investigations of deviations, OOS/OOT results, CAPAs, root cause analyses, and timely closure of quality events.
  • Support inspection readiness, audits, risk management, quality metrics, APRs, FARs, recalls, and product withdrawal activities.
  • Ensure data integrity and compliance for regulatory submissions and maintain alignment with source documentation.
  • Coordinate with CDMOs, contract testing laboratories, Technical Operations, Analytical Development, QC, and CMC Regulatory Affairs.
  • Maintain awareness of evolving veterinary pharmaceutical regulations and update compliance strategies as needed.

Requirements

  • B.S. or M.S. degree in a scientific discipline such as Pharmaceutical Sciences, Chemistry, Veterinary Science, or a related field.
  • Minimum 12 years of relevant pharmaceutical industry experience, including at least 6 years in GxP QA roles.
  • Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products.
  • In-depth knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems.
  • Experience managing CDMOs and working effectively across cross-functional teams.
  • Ability to work independently and in a team or matrix environment.
  • Ability to manage multiple assignments, meet deadlines, and work with strong attention to detail and accuracy.
  • Strong written and verbal communication skills.
  • Willingness to travel 10%.
  • Preferred: compliance or regulatory certifications such as RAC or ASQ.
  • Preferred: experience auditing suppliers, CDMOs, and CTLs.
  • Preferred: experience with Google Workspace and electronic Quality Management Systems.
  • Preferred: 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 such as the EU or Canada.

Benefits

  • Salary range of $150,000 to $190,000.
  • Competitive salary.
  • Company equity options grant for new hires.
  • Full-coverage medical, dental, and vision insurance for employees and dependents.
  • $1,000 home office equipment stipend.
  • $1,200 annual learning budget for books, courses, and similar development expenses.
  • $250 monthly wellness budget for gym, cleaners, spa, food, and related expenses.
  • Unlimited vacation, paid holidays, and all 3-day weekends turned into 4-day weekends.
  • Paw-ternity leave with a day off when you adopt a dog.

Interested in this position?

Apply directly on the company website

Apply Now

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