Senior Director, Analytical Development

Accountabilities:: Define and execute the global analytical development and quality control strategy, aligning scientific priorities with broader corporate and CMC objectives. Serve as the accountable executive for GMP analytical operations, ensuring inspection-ready systems, data integrity, pre-approval inspection readiness, and sustained regulatory compliance across internal and external operations. Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, resource allocation, and investment decisions. Lead analytical method development, validation, transfer, and lifecycle management, with an initial focus on small-molecule oral solid dosage products and support for additional modalities as the pipeline expands. Own dissolution strategy, including discriminating method development, validation, and preparation of dissolution data packages for regulatory submissions. Author and review analytical content for NADA CMC technical sections, including method validation summaries, specification justifications, stability narratives, and regulatory deficiency responses. Direct drug substance analytical strategy, including methods, specifications, impurity controls, stability programs, reference standards, and testing at API manufacturers and starting material suppliers. Establish and oversee stability strategies across the pipeline, covering protocol design, statistical evaluation, shelf-life assignment, and ongoing data trending. Lead cross-functional definition and lifecycle management of critical quality attributes (CQAs), specifications, and analytical control strategies. Establish and oversee commercial QC operations, including governance and performance management of external GMP testing laboratories and service providers. Provide executive oversight of deviations, investigations, out-of-specification (OOS) and out-of-trend (OOT) events, and corrective and preventive actions (CAPAs). Serve as a senior analytical subject-matter expert in interactions with the FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, supporting submissions, responses, meetings, and inspections. Select, manage, and govern external analytical laboratories, contract development and manufacturing organizations (CDMOs), and other partners, ensuring technical quality, compliance, and cost effectiveness. Build and scale a high-performing analytical development and QC organization, including hiring, mentoring, and developing senior technical leaders. Establish operating models that balance internal capabilities with strategic outsourcing, while planning resources and budgets around pipeline priorities and long-term business needs. Requirements: Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline. 18+ years of progressive experience in pharmaceutical analytical development and quality control, with deep expertise in small-molecule oral solid dosage forms. Demonstrated experience spanning early-stage development, clinical programs, commercial launch, and post-approval product lifecycle management. Proven success building and leading analytical development and/or QC organizations, including hiring, mentoring, and developing senior technical leaders. Extensive hands-on expertise in analytical method development, phase-appropriate validation, method transfer, and GMP quality control operations. Direct experience engaging with the FDA on regulatory submissions, responses, meetings, and inspections, alongside a working knowledge of ICH guidelines. Track record overseeing external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution. Demonstrated success leading analytical and control-strategy content for NADA/NDA CMC submissions through approval, including deficiency responses and pre-approval inspections. Strong understanding of analytical science and regulatory requirements, with the ability to translate complex technical issues into clear business recommendations. Strategic leadership skills and the ability to balance hands-on technical contribution with executive-level decision-making in a fast-paced, growth-stage environment. Excellent communication and influencing skills, with the ability to work credibly with executive leadership, regulators, scientific teams, and external partners. Preferred: familiarity with animal health regulatory requirements, including FDA CVM and VICH guidelines. Benefits: Base salary range of $230,000–$280,000 USD . Eligibility for a company equity options grant. Full-coverage medical, dental, and vision insurance for employees and dependents. $1,000 home office equipment stipend. Annual learning budget of $1,200 for books, courses, and professional development. Monthly wellness budget of $250, which can be used for eligible wellness-related expenses. Unlimited vacation and paid holidays. Three-day weekends extended to four-day weekends. One day of paid leave to welcome a newly adopted dog. Remote work within the United States.