Scientist, Analytical Development

The Role

In this role, you will join the Analytical Sciences team within Analytical Development and serve as a scientific lead for the transfer and implementation of analytical methods developed in AD into Analytical Testing Operations (ATO) and Quality Control (QC) laboratories. You will assess method readiness, design and execute phase-appropriate transfer strategies, and work directly with sending and receiving laboratories to ensure methods are scientifically understood, reproducible, operationally robust, and fit for their intended use.

Success in this role requires substantial hands-on analytical method development experience, a strong understanding of analytical method performance and failure modes, practical experience executing and troubleshooting method transfers, and a solid grasp of GMP and global regulatory expectations. You will partner closely with AD method developers, APLs, ATO, Analytical Sciences & Technology (AST), QC, Quality, Quantitative Sciences, and Regulatory to build a durable feedback loop between development and routine testing and to improve analytical performance across the network.

• 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-lab 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…