Senior Director, Analytical Development

This executive-level role offers the opportunity to lead analytical development and quality control strategy across a growing pharmaceutical pipeline, from early development through commercial launch and post-approval lifecycle management. You’ll combine deep scientific expertise with hands-on leadership, shaping analytical methods, control strategies, and GMP operations for small-molecule oral solid dosage products and future modalities. Working across internal teams and external laboratories, you’ll ensure analytical readiness, data integrity, and regulatory compliance while supporting critical development milestones. You’ll also play a central role in preparing and authoring CMC submission content, engaging with FDA regulators, and guiding responses to technical questions and inspections. In a lean, virtual, growth-stage environment, you’ll build and develop a high-performing analytical organization while balancing strategic decisions with direct technical contribution. This is a remote position within the United States.

• 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.