Associate Director, Small Molecule Analytical Development

About This Role

The Associate Director, Small Molecule Analytical Development will provide scientific and people leadership for analytical development activities supporting small molecule programs from early clinical development through late-stage registration and commercialization. This role is responsible for developing phase-appropriate analytical strategies, overseeing method development and validation, supporting impurity control and specification setting, and contributing to CMC regulatory submissions. The position works closely with cross-functional partners and external organizations to support reliable clinical supply, regulatory readiness, and commercialization objectives.

Who We Are

The Small Molecule Analytical Development team develops analytical methods, control strategies, and supporting data packages for small molecule therapeutics. The team partners with process chemistry, chemical engineering, solid form, formulation, quality, regulatory CMC, manufacturing, clinical supply, and external development partners to support development programs and regulatory submissions. The team emphasizes scientific rigor, collaboration, data-driven decision-making, operational excellence, and continuous improvement.

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.

• 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.

• 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.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation