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Senior Director, Quality Control & Analytical Development

Role overview

Qualifications

  • Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline
  • 18+ years of progressive experience in analytical development and quality control for pharmaceutical products
  • Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations
  • Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines

Responsibilities

  • Set and execute the global analytical development and quality control strategy
  • Own the end-to-end analytical and QC lifecycle from early development through commercialization
  • Serve as the accountable executive for GMP analytical and QC operations
  • Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies

Key facts

Other skills

  • Quality Control
  • Knowledge Transfer
  • Strategic Thinking
  • Communication
  • Influencing Skills
  • Leadership
  • Mentorship
  • Team Building

About the company

Loyal logo

Loyal

Biotech: Biology + Technology

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. In other words, our mission is to help dogs live longer, healthier lives. We’ve already achieved significant milestones on our path to gaining FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and expect to bring the first product to market in 2025. Our team includes scientists, veterinarians, engineers, operators, and creatives. Join us in our mission to help dogs everywhere.

Company details

Company typeScaleup
IndustryBiotech: Biology + Technology
Company size51 - 200

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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 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

The Senior Director of Quality Control & Analytical Development will be providing strategic leadership for all analytical development and commercial quality control across Loyal’s pipeline and marketed products. You will oversee the full QC lifecycle from early development through commercialization, ensuring robust control strategies, regulatory compliance, and operational excellence. Builds and scales the QC/AD organization, leveraging internal and external partners, with deep expertise in OSD analytics and animal health regulatory requirements.

Your daily work will include

  • Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives.
  • Own the end-to-end analytical and QC lifecycle from early development through commercialization, including commercial QC readiness, product release, stability programs, and post-approval lifecycle management.
  • Serve as the accountable executive for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance.
  • Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions.
  • Lead the development, validation, transfer, and lifecycle management of analytical methods and control strategies, with immediate focus on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves.
  • Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies.
  • Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers.
  • Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities.
  • Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections.
  • Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness.
  • Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders.
  • Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and commercial portfolio.
  • Manage resource planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives.

About you 

  • Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
  • 18+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms.
  • Demonstrated experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management.
  • Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders.
  • Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.
  • Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines (e.g., VICH; ICH as applicable), with direct experience supporting regulatory submissions and inspections.
  • Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution.
  • Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations.
  • Comfortable operating in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making.
  • Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners.

Salary Range: $230,000 - $280,000

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.

 

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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