Senior Director, Analytical Development (Pharmaceutical Analytics)

Location: Remote - US

Salary: $230,000–$280,000 per year

Company

hirify.global is a well-funded clinical-stage veterinary medicine startup developing longevity drugs for dogs and pursuing FDA approval for canine lifespan-extension medicines.

What you will do

• Set and execute the analytical development and quality control strategy across the pipeline and future commercial products.
• Lead analytical method development, validation, transfer, lifecycle management, dissolution strategy, stability programs, specifications, impurity control, and control strategies.
• Own GMP analytical operations, inspection readiness, data integrity, PAI readiness, deviations, investigations, OOS/OOT events, and CAPAs.
• Author and review analytical content for NADA CMC technical sections, including validation summaries, specification justifications, stability narratives, and deficiency responses.
• Provide senior CMC and analytical expertise in cross-functional programs and interactions with FDA CVM and other animal-health regulators.
• Build and lead the QC and analytical development organization while managing external laboratories, CDMOs, budgets, resources, and strategic outsourcing.

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, including deep expertise in small-molecule oral solid dosage forms.
• Experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management.
• Experience 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 FDA experience with regulatory submissions, responses, meetings, and inspections, plus working knowledge of ICH guidelines.
• Experience overseeing external GMP testing laboratories and analytical service providers, including performance management and quality issue resolution.
• Experience leading analytical and control-strategy content for NADA/NDA CMC sections through approval, including deficiency responses and pre-approval inspections.
• Strategic, communication, and influencing skills for engaging executive leaders, regulators, and external partners in a fast-paced growth-stage environment.

Nice to have

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

Culture & Benefits

• Lean, virtual, cross-functional environment with a hands-on leadership model.
• Full-coverage medical, dental, and vision insurance for employees and dependents.
• $1,000 home-office equipment stipend and $1,200 annual learning budget.
• $250 monthly wellness budget, unlimited vacation, paid holidays, and extended holiday weekends.
• Paw-ternity leave for adopting a dog and company equity options for new hires.
• Culture centered on methodological rigor, cross-disciplinary collaboration, transparency, humility, agency, and respect for all life.