Associate Director, Analytical Development

1 week ago

Boston, United States Stratacuity: Proven Scientific Placement Full time

Associate Director, Analytical Development Our client is seeking an accomplished leader to join our team as Associate Director, Analytical Development (Small Molecules). This role will drive analytical strategy and execution for late-phase development programs, ensuring robust data packages to support NDA submissions and eventual commercialization. The ideal candidate brings deep expertise in small molecule analytical methods, regulatory expectations, and cross‑functional collaboration to deliver high‑quality CMC data. Base Pay Range $95.00/hr - $125.00/hr Key Responsibilities Analytical strategy for late-phase programs: Develop and implement analytical plans aligned with NDA submission timelines and regulatory requirements. Method validation & transfer: Lead validation of chromatographic, spectroscopic, and dissolution methods per ICH/FDA guidelines; oversee method transfers to QC/ manufacturing sites. Stability & release testing: Ensure comprehensive stability studies and product release testing packages are generated and interpreted. Regulatory documentation: Author and review analytical sections of IND amendments, NDA filings, and responses to regulatory queries. Cross‑functional leadership: Partner with Formulation, Process Development, Quality, and Regulatory Affairs to ensure analytical deliverables meet program milestones. Team management: Mentor scientists, set priorities, and foster technical excellence in method development and validation. Inspection readiness: Prepare analytical teams and documentation for pre‑approval inspections (PAI). Innovation & compliance: Evaluate new technologies (e.g., LC‑MS, UPLC) while ensuring strict adherence to GMP and data integrity standards. Qualifications Ph.D. or M.S. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline. 10+ years in small molecule analytical development, with significant late‑phase/NDA submission experience. Strong background in HPLC/UPLC, LC‑MS, dissolution, impurity profiling, and stability testing. Proven track record authoring CMC sections of NDAs; deep familiarity with ICH Q2(R2), FDA guidance, and global regulatory expectations. Demonstrated ability to lead teams, manage timelines, and influence cross‑functional stakeholders in a matrixed environment. #J-18808-Ljbffr

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