Associate Director, CMC Analytical Development – Small Molecule

Job Summary:

The Associate Director, CMC Analytical Development – Small Molecule is a senior analytical scientist and individual contributor responsible for the development, qualification, and validation of analytical methods supporting small molecule drug substance and drug product programs. Reporting to the Executive Director, CMC Analytical Development, this individual serves as the primary technical owner for analytical activities on assigned programs, covering method development, characterization, stability, and analytical sections of regulatory submissions. This role carries no direct reports but is the key scientific interface with contract analytical laboratories and CDMO analytical teams. It requires deep expertise in small molecule analytical development and testing, a knowledge of GMP laboratory practices, and the ability to manage analytical workstreams independently in a pre-commercial, fast-moving biotech environment.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Lead the development, qualification, and validation of analytical methods for small molecule APIs and drug products, including assay, related substances, residual solvents, elemental impurities, dissolution, and physicochemical characterization methods.
• Serve as the primary analytical technical lead for assigned small molecule programs, owning the analytical control strategy from early development through IND, Phase 1–3, and NDA regulatory submissions.
• Design and oversee forced degradation studies, stress testing, and ICH Q1-compliant stability programs for small molecule drug substance and drug product, including protocol development, data review, and shelf-life determination.
• Author and review analytical sections of regulatory submissions including INDs, IMPDs, and NDA modules, and contribute to responses to agency questions on analytical topics with scientific rigor and regulatory awareness.
• Manage method transfer activities to and from contract analytical laboratories and CDMO sites, ensuring methods are transferred, validated, and operationally robust in receiving laboratory.
• Establish and enforce data integrity practices, laboratory compliance standards, and GMP documentation expectations across the small molecule analytical function in alignment with FDA and ICH guidance.
• Evaluate and implement advanced analytical technologies and instrumentation to improve method sensitivity, throughput, and scientific insight across small molecule characterization workflows.
• Partner with Process Chemistry and Product Development teams to provide analytical support for manufacturing campaigns, including in-process testing, impurity profiling, and polymorph/salt form characterization.
• Contribute to the development and review of specifications, certificates of analysis, and release testing strategies for drug substance and drug product, in alignment with regulatory expectations and clinical program needs.
• Operate as a self-directed analytical contributor — independently managing method development priorities, analytical study plans, and GMP documentation while proactively communicating progress, risks, and results to the CMC leadership team and cross-functional partners.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline preferred; or equivalent industry experience in pharmaceutical analytical development.
• 7+ years of pharmaceutical analytical development experience focused on small molecules in pharmaceutical or biotechnology industry.
• Demonstrated track record of serving as the primary analytical lead on drug substance and drug product programs across multiple development phases.
• Deep expertise in small molecule analytical method development and validation using HPLC, UHPLC, LC-MS, GC, Karl Fischer, dissolution, and related techniques in compliance with ICH Q2(R1) and USP/EP requirements.
• Experience authoring analytical sections of INDs, IMPDs, and NDA filings, and responding to FDA or EMA information requests on analytical methods, specifications, or stability data.
• Proven experience managing method transfer to contract analytical laboratories, including transfer protocol development, method validation oversight, and out-of-specification investigation management.
• Demonstrated experience serving as the primary analytical lead on CMC programs, with the ability to set scientific direction, prioritize workstreams, and drive program accountability without direct reports.
• Skilled in managing external partner relationships including CDMOs and contract laboratories, with hands-on experience in technical oversight, work order management, change control, deviation resolution, and performance monitoring at the working level.
• Strong written and verbal communication skills, with the ability to clearly present scientific data, development recommendations, and program updates to senior leadership and cross-functional partners.
• Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Regulatory Affairs, and Quality in a team-oriented environment.
• Organized and detail-oriented communicator who can manage competing priorities, proactively flag risks, and keep cross-functional stakeholders aligned on timelines and deliverable status.