Senior Director, Analytical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement the global analytical development and quality control strategy in alignment with Loyal’s corporate and CMC goals.

• Act as the accountable executive for GMP analytical operations, ensuring systems are inspection-ready, data integrity is maintained, and PAI readiness is achieved at Loyal and CDMOs, while upholding regulatory compliance.

• Serve as a senior CMC leader within cross-functional program teams, guiding development strategies, timelines, and investment choices.

• Oversee the development, validation, transfer, and lifecycle management of analytical methods and control strategies for small-molecule oral solid dosage products and other modalities.

• Take charge of the dissolution strategy, which includes the development, validation, and preparation of dissolution data packages for CVM submissions.

• Write and review analytical content for NADA CMC technical sections, encompassing method validation summaries, specification justifications, stability narratives, and responses to deficiencies.

• Guide the analytical strategy for drug substances, addressing method development and validation, specifications, impurity control, stability programs, reference standards, and testing at API manufacturers and starting material suppliers.

• Direct the stability strategy, including protocol design, statistical evaluation, shelf-life assignment, and trend analysis.

• Lead the identification and lifecycle management of CQAs, specifications, and control strategies across functions.

• Establish and manage commercial QC operations, including oversight of external GMP testing laboratories and service providers.

• Provide executive oversight for deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities.

• Act as a senior analytical subject-matter expert in engagements with FDA CVM and other global animal health regulatory agencies, including submissions, responses, and inspections.

• Select, manage, and oversee external analytical laboratories, CDMOs, and other collaborators.

• Build, expand, and lead a high-performing QC and analytical development organization, including recruitment, mentoring, and development of senior technical leaders.

• Develop operating models that balance internal capabilities with strategic outsourcing.

• Manage 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 field.

• Over 18 years of progressive experience in analytical development and quality control for pharmaceutical products, with extensive knowledge in small-molecule oral solid dosage forms.

• Proven experience across early development, clinical programs, commercial launches, and post-approval lifecycle management.

• A successful track record in building and leading analytical and/or QC teams, including recruitment, mentoring, and the development of senior technical leaders.

• Significant experience in analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.

• Direct experience with the FDA regarding regulatory submissions, responses, meetings, and inspections, along with a solid understanding of ICH guidelines.

• Proven ability to effectively oversee external GMP testing laboratories and analytical service providers, including governance, performance management, and resolution of quality issues.

• History of leading the analytical and control-strategy content of NADA/NDA CMC sections through approval, including responses to deficiencies and pre-approval inspections.

• A strategic mindset capable of translating scientific and regulatory complexities into clear, actionable business recommendations.

• Ability to thrive in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making.

• Exceptional communication and influencing skills, with the capability to engage credibly with executive leadership, regulators, and external partners.

• Preferred: Familiarity with animal health regulatory requirements, including FDA CVM and VICH guidelines.

🏝️ Benefits

• Comprehensive health insurance coverage — medical, dental, and vision — for you and your dependents.

• $1,000 stipend for home office equipment.

• Annual learning budget of $1,200 for books, courses, and more.

• Monthly wellness budget of $250 for gym memberships, cleaning services, spa treatments, food, etc.

• All 3-day weekends are extended to 4-day weekends.

• Unlimited vacation and paid holidays.

• Paw-ternity leave — take a day off to welcome your new dog into your family.

• Competitive salary.

• Company equity options grant for new hires.