Scientist, Analytical Development

Here’s What You’ll Do

Serve as the Analytical Sciences technical transfer lead for assigned analytical methods moving from Analytical Development into ATO and QC laboratories, driving transfer activities from readiness assessment through execution, troubleshooting, and transfer closeout.

Perform rigorous method-transfer readiness assessments using development and qualification data, robustness knowledge, method risk assessments, critical method parameters, system suitability, assay controls, reference standards, critical reagents, sample preparation, data processing, and known method limitations.

Define and execute phase-appropriate transfer strategies, protocols, acceptance criteria, and study designs that reflect the method’s intended use, product-development phase, scientific maturity, and patient/product risk.

Partner with method-development scientists before formal handoff to improve transferability, including strengthening method robustness, operational ranges, procedural clarity, system suitability and assay controls, critical-material controls, and troubleshooting guidance.

Apply strong hands‑on laboratory expertise during method transfer as needed to reproduce methods, train receiving-laboratory analysts, evaluate analyst/instrument/site effects, and rapidly resolve technical barriers to successful execution.

Lead scientific troubleshooting and root‑cause investigations during transfer and early routine use, designing targeted experiments to distinguish method, sample, reagent, instrument, software, analyst, and laboratory‑environment sources of variability and implementing durable corrective actions.

Ensure development knowledge is translated into complete and usable transfer packages, including scientific rationale, critical steps and parameters, method failure modes, material and reagent requirements, expected performance, data‑analysis conventions, and practical troubleshooting guidance.

Partner with AST, QC, Quality, ATO, and Regulatory to align method qualification, validation, verification, and transfer expectations with ICH Q2(R2), ICH Q14, USP , applicable GMP requirements, and phase‑appropriate principles for clinical development.

Provide scientific support for deviations, OOS/OOT investigations, change controls, CAPAs, and post‑transfer stabilization when method performance or execution issues arise, ensuring that troubleshooting remains grounded in method‑development knowledge and scientific rationale.

Build and improve standardized transfer playbooks, templates, readiness criteria, and best practices across method families, helping establish consistent expectations for transfers into clinical and commercial testing laboratories.

Monitor transfer outcomes and early method‑performance trends, capture lessons learned, and feed findings back to Analytical Development and Analytical Sciences to drive continual method improvement, platform harmonization, and stronger future method designs.

Author and review transfer protocols and reports, analytical procedures, risk assessments, technical summaries, training materials, change‑control documentation, and regulatory‑supporting content with a high standard of scientific rigor and data integrity.

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 2+ years of relevant industry experience, or M.S. with 8+ years, or B.S./B.A. with 12+ years of relevant experience in analytical development, analytical sciences, Quality Control, or related pharmaceutical development functions.

Strong hands‑on analytical method development experience, with demonstrated…