Associate Director, CMC Analytical Development – Small Molecule

About the role

The Associate Director, CMC Analytical Development – Small Molecule is a senior analytical scientist responsible for the development, qualification, and validation of analytical methods supporting small molecule drug substance and drug product programs. This role serves as the primary technical owner for analytical activities on assigned programs, covering method development, characterization, stability, and analytical sections of regulatory submissions. The role 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.

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.
• 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—individually 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.

Requirements

• Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline preferred; or equivalent industry experience in pharmaceutical analytical development.
• Experience: 7+ years of pharmaceutical analytical development experience focused on small molecules in pharmaceutical or biotechnology industry.
• Expertise: 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.
• Management: Proven experience managing method transfer to contract analytical laboratories, including transfer protocol development, method validation oversight, and out-of-specification investigation management.
• Leadership: 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.
• Collaboration: 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.
• Communication: 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.
• Organization: Organized and detail-oriented communicator who can manage competing priorities, proactively flag risks, and keep cross-functional stakeholders aligned on timelines and deliverable status.

Qualifications

• Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline preferred; or equivalent industry experience in pharmaceutical analytical development.
• Experience: 7+ years of pharmaceutical analytical development experience focused on small molecules in pharmaceutical or biotechnology industry.
• Expertise: 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.
• Management: Proven experience managing method transfer to contract analytical laboratories, including transfer protocol development, method validation oversight, and out-of-specification investigation management.
• Leadership: 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.
• Collaboration: 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.
• Communication: 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.
• Organization: Organized and detail-oriented communicator who can manage competing priorities, proactively flag risks, and keep cross-functional stakeholders aligned on timelines and deliverable status.