Associate Director, CMC Analytical Development - Small Molecule

Requirements

• 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, dis

Additional Information

About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully. 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

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