Senior Director, Analytical Development

Loyal

2d • $230,000 - $280,000

About The Position

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. The Senior Director, Analytical Development provides strategic leadership for analytical development across Loyal’s pipeline and future commercial products. This hands-on role in a lean, virtual company combines setting strategy with executing technical work, including authoring analytical content for CVM submissions. The role will build and scale the analytical development organization using internal and external partners, with a focus on oral solid dosage analytics and FDA regulatory requirements. The position reports to the Vice President of Manufacturing.

The Senior Director will lead analytical development and quality control strategy, GMP analytical operations, analytical methods and control strategies, stability programs, dissolution strategy, and commercial QC operations. They will author and review analytical content for NADA CMC submissions, represent Loyal in regulatory interactions, oversee external laboratories and CDMOs, and build a high-performing analytical development and QC organization. The role also includes resource and budget planning aligned with pipeline priorities and long-term business objectives.

Requirements

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
• At least 18 years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms.
• Experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management.
• Demonstrated 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.
• Direct experience interacting with FDA on regulatory submissions, responses, meetings, and inspections, with working knowledge of ICH guidelines.
• Experience overseeing external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution.
• Track record leading analytical and control-strategy content of NADA/NDA CMC sections through approval, including deficiency responses and pre-approval inspections.
• Strategic mindset and ability to translate scientific and regulatory complexity into clear, actionable business recommendations.
• Ability to work in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making.
• Excellent communication and influencing skills, including the ability to engage credibly with executive leadership, regulators, and external partners.

Nice To Haves

• Knowledge of animal health regulatory requirements, including FDA CVM and VICH guidelines.

Responsibilities

• Set and execute the global analytical development and quality control strategy in alignment with corporate and CMC objectives.
• Serve as accountable executive for GMP analytical operations, ensuring inspection-ready systems, data integrity, pre-approval inspection readiness at Loyal and CDMOs, and sustained regulatory compliance.
• Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions.
• Lead development, validation, transfer, and lifecycle management of analytical methods and control strategies, initially focused on small-molecule oral solid dosage products and supporting additional modalities as the pipeline evolves.
• Own dissolution strategy, including discriminating method development and validation and the dissolution data package for CVM submissions.
• Author and review analytical content of the NADA CMC technical section, including method validation summaries, specification justifications, stability narratives, and deficiency responses.
• Lead drug substance analytical strategy, including method development and validation, specifications, impurity control, stability programs, reference standards, and testing at API manufacturers and starting material suppliers.
• Own stability strategy across the pipeline, including protocol design, statistical evaluation, shelf-life assignment, and trending.
• Lead cross-functional identification and lifecycle management of critical quality attributes, 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, out-of-specification and out-of-trend events, and CAPAs related to analytical and QC activities.
• Serve as a senior analytical subject-matter expert in interactions with FDA CVM and other global animal health regulatory agencies, including 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 balancing internal capabilities with strategic outsourcing to support a growing and commercial portfolio.
• Manage resource and budget planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives.

Benefits

• Full-coverage medical, dental, and vision insurance for employees and dependents.
• $1,000 home office equipment stipend.
• $1,200 per year learning budget for books, courses, and other learning expenses.
• $250 per month wellness budget.
• Three-day weekends are extended to four-day weekends.
• Unlimited vacation and paid holidays.
• Paw-ternity leave: a day off to adopt a dog and welcome the new family member.
• Competitive salary.
• Company equity options grant for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior