Senior Director, Analytical Development
L
LoyalVeterinary pharmaceuticals
Remote - USFull-TimeDirector
SalarySalary Range: $230,000 - $280,000
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Job Details
- Experience
- 18+ years of progressive experience in analytical development and quality control for pharmaceutical products
Requirements
- Hold a Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
- Bring 18+ years of progressive experience in pharmaceutical analytical development and quality control.
- Have deep expertise in small-molecule oral solid dosage forms.
- Demonstrate experience from early development and clinical programs through commercial launch and post-approval lifecycle management.
- Have experience building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders.
- Bring extensive experience in analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.
- Have direct experience with FDA submissions, responses, meetings, and inspections, and working knowledge of ICH guidelines.
- Have experience overseeing external GMP testing laboratories and analytical service providers, including performance management and quality issue resolution.
- Have led analytical and control-strategy content for NADA/NDA CMC sections through approval, including deficiency responses and pre-approval inspections.
- Preferred: knowledge of animal health regulatory requirements, including FDA CVM and VICH guidelines.
- Be able to translate scientific and regulatory complexity into actionable business recommendations and engage with executives, regulators, and external partners.
Responsibilities
- Set and execute global analytical development and quality control strategy aligned with corporate and CMC objectives.
- Oversee GMP analytical operations, inspection readiness, data integrity, PAI readiness, and regulatory compliance.
- Lead analytical method development, validation, transfer, and lifecycle management, initially focused on small-molecule oral solid dosage products.
- Own dissolution strategy and the dissolution data package for CVM submissions.
- Author and review analytical content for NADA CMC sections, including validation summaries, specification justifications, stability narratives, and deficiency responses.
- Lead drug substance analytical strategy, including specifications, impurity control, stability programs, reference standards, and supplier testing.
- Own stability strategy, including protocol design, statistical evaluation, shelf-life assignment, and trending.
- Establish commercial QC operations and oversee external GMP testing laboratories and service providers.
- Oversee analytical and QC deviations, investigations, OOS/OOT events, and CAPAs; engage with FDA CVM and other regulatory agencies.
- Build and lead the QC and analytical development organization, manage external partners, and plan resources and budgets.
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