Associate Director, Small Molecule Analytical Development

What You’ll Do

• Lead analytical development activities for small molecule drug substance and drug product programs, including method development, qualification, validation, transfer, lifecycle management, and routine control strategy support.
• Develop and implement phase-appropriate analytical control strategies for identity, assay, impurities, degradation products, residual solvents, elemental impurities, solid-state attributes, dissolution, and other critical quality attributes.
• Provide technical guidance for impurity identification and characterization, forced degradation, stability strategy, comparability assessments, and specification justification.
• Represent Analytical Development on cross-functional CMC project teams and contribute to project strategy, risk assessment, planning, and decision-making.
• Author and review analytical content for regulatory submissions and technical documents, including INDs, CTAs, NDAs/MAAs, briefing packages, responses to health authority questions, validation reports, transfer reports, and internal technical reports.
• Collaborate with Process Chemistry, Chemical Engineering, Solid Form, Formulation, Quality, Regulatory CMC, Manufacturing, and Clinical Supply to align analytical methods and specifications with process understanding, product performance, and program needs.
• Oversee analytical activities conducted by contract research, development, and manufacturing organizations, including review of protocols, reports, results, timelines, and quality expectations.
• Manage, mentor, and develop scientists, supporting performance, career development, inclusive teamwork, and a culture of accountability and continuous improvement.
• Evaluate and implement analytical technologies, digital tools, automation, and data approaches that improve productivity, method robustness, compliance, and decision-making.
• Represent the function internally and, as appropriate, externally through scientific presentations, publications, professional organizations, consortia, or industry forums.

Required Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, Chemistry, Chemical engineering, or a related scientific discipline with 6 or more years of relevant experience in pharmaceutical or biotechnology development; or M.S. in a relevant scientific discipline with 8 or more years of relevant experience in pharmaceutical or biotechnology development; or B.S. in a relevant scientific discipline with 10 or more years of relevant experience in pharmaceutical or biotechnology development.
• Experience in small molecule analytical development, including chromatographic and/or spectroscopic method development, validation, transfer, impurity profiling, stability, and specification setting.
• Working knowledge of regulatory expectations and quality standards applicable to analytical development and CMC submissions, including relevant ICH guidance and GMP principles.
• Experience leading analytical workstreams, project teams, or cross-functional CMC activities in a matrixed environment.
• Experience managing, mentoring, or developing scientific staff.
• Strong written and verbal communication skills, including the ability to communicate scientific information clearly to technical and non-technical audiences.

Preferred Qualifications

• Experience supporting small molecule programs from early development through late-stage registration, launch, or post-approval lifecycle management.
• Experience with impurity identification and control, degradation pathway assessment, mass spectrometry, NMR, solid-state characterization, dissolution, or drug product analytical development.
• Experience working with external partners, including CROs, CDMOs, and QC laboratories.
• Experience contributing to regulatory submissions or responses to health authority questions.
• Experience with digital analytical workflows, automation, electronic laboratory systems, modeling, data visualization, or emerging analytical technologies.
• Scientific contributions through publications, presentations, professional society engagement, consortia participation, or other external scientific activities.