Senior Director, Analytical Development CMC

For our client, we are seeking a Senior Director, Analytical Development CMC to join the team of a leader in the Pharmaceuticals & Biotech space. This remote leadership role will guide analytical development strategy across early phase programs, with a focus on small molecule oral solid dosage forms. The position will partner closely with internal development, quality, regulatory, and external vendor teams to advance method development, characterization, validation, and filing support. It is a highly visible role that will shape analytical decisions, support compliance, and help ensure program readiness from development through regulatory submission. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $153,000 – $290,400 annually Responsibilities Lead analytical strategy for phase-appropriate method development and product characterization Collaborate with internal teams to manage drug substance and product analytical development at third-party vendors Review validation protocols and test data for release and stability Oversee documentation storage and generate stability result tables Set specifications based on batch history and analytical data Represent the analytical function in program development teams Mentor junior scientists and serve as a subject matter expert Contribute to regulatory filings and responses to regulatory inquiries Assist quality teams in troubleshooting analytical issues Participate in batch record reviews Qualifications Advanced degree in chemistry, pharmaceutical sciences, or a related field; PhD preferred 10+ years of small molecule pharmaceutical industry experience Extensive experience in early phase analytical development of small molecule oral solid dosage forms Deep expertise in cGMP and ex-US regulatory requirements Strong technical background in chemical and physical characterization Significant experience in analytical method development and GMP qualification/validation Proven ability to manage and direct outsourced analytical activities at CDMOs Benefits Eligibility for a company-sponsored 401(k) and pension plan Vacation benefits and flexible leave options Comprehensive medical, dental, vision, and prescription drug benefits Life insurance and death benefits Well-being benefits, including employee assistance and fitness programs Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.