The Director, Analytical Development will lead analytical and CMC strategy, manage external partners, and drive cross-functional execution in a fast-paced, evolving environment. The Director, Analytical Development role is a direct placement with the company and allows the candidate to work remotely in the United States with travel up to 30%.

Responsibilities of the Director, Analytical Development:
• Lead analytical development activities for a key pharmaceutical development program.
• Represent CMC and Analytical Development on cross-functional project teams.
• Develop and execute analytical strategies supporting formulation, clinical, and regulatory goals.
• Manage CROs, contract laboratories, and external development partners.
• Drive technical decision-making and program execution under aggressive timelines.
• Partner with formulation, clinical, regulatory, and project management stakeholders.
• Identify and implement solutions to complex development challenges.
• Establish processes and structure within a dynamic development environment.

Requirements of the Director, Analytical Development:
• Ph.D., M.S., or B.S. in Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline.
• 7+ years of pharmaceutical or biotechnology industry experience in Analytical Development.
• Director-level experience or Associate Director ready for promotion.
• Strong background in analytical method development, characterization, and validation.
• Understanding of formulation development and broader CMC activities.
• Experience managing CROs, vendors, and external laboratories.
• Proven ability to lead highly visible, cross-functional development programs.
• Exceptional communication, leadership, and stakeholder management skills.
• Ability to thrive in ambiguous environments with shifting priorities.

Compensation for the Director, Analytical Development:
• $140,000 - $170,000 base salary
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.

Keywords:

Director Analytical Development, Analytical Development, CMC, Chemistry Manufacturing and Controls, Pharmaceutical Development, Formulation Development, CRO Management, Vendor Management, Method Development, Method Validation, Drug Product Development, Regulatory Support, Technical Leadership, Cross-Functional Leadership, Pharmaceutical Sciences, Lifecycle Management, Clinical Development Support, Analytical Strategy, Biotechnology, GMP, Stability Studies, Program Leadership, Stakeholder Management, Scientific Leadership

This job opens for applications on 09/25/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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