Scientist, Analytical Development

Moderna • Norwood, MA

21h • $109,200 - $174,600 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Strong hands-on analytical method development experience, with demonstrated ability to optimize methods, establish robustness, understand method failure modes, and translate scientific knowledge into reliable routine procedures.
• Direct experience executing multiple analytical method transfers into GMP or GMP-supporting laboratories, with strong preference for candidates who have led transfers across different methods, products, laboratories, or sites.
• Demonstrated expertise troubleshooting difficult analytical method-performance issues during transfer or routine testing and designing scientifically sound experiments to identify root causes and implement sustainable solutions.
• Strong working knowledge of analytical procedure development, qualification, validation, verification, and lifecycle principles, including ICH Q2(R2), ICH Q14, USP <1224>, quality risk management, and data-integrity expectations.
• Solid understanding of phase-appropriate GMP principles and the ability to apply an appropriate level of analytical rigor, documentation, controls, and validation based on clinical phase, intended use, method maturity, and risk.
• Scientific depth in one or more major analytical technology areas such as chromatography/separation science, electrophoresis, spectroscopy, compendial testing, molecular methods, bioassays, or other analytical platforms relevant to biologics, vaccines, nucleic acids, or advanced modalities.
• Experience assessing laboratory-to-laboratory differences in instrumentation, software, reagents, reference standards, sample preparation, environmental conditions, and analyst technique and determining appropriate bridging or mitigation strategies.
• Strong understanding of system suitability, assay controls, critical reagents and materials, reference-standard strategy, statistical assessment of method performance, and the relationship between method robustness and successful transfer.
• Experience supporting deviations, OOS/OOT investigations, change controls, CAPAs, method remediation, or lifecycle changes in a regulated analytical environment.
• Experience working across Analytical Development, QC, Quality, Regulatory, AS&T/MS&T, and/or external testing laboratories, with the ability to translate development science into practical expectations for routine laboratory execution.
• Experience with mRNA, LNP, vaccines, biologics, or other advanced therapeutic modalities is preferred.
• Excellent technical writing, communication, collaboration, and stakeholder-management skills, with the ability to explain complex analytical issues clearly, influence cross-functional decisions, and maintain scientific rigor in a fast-moving environment.
• Self-motivated, highly collaborative, and comfortable combining hands-on technical work with cross-functional leadership, with a desire to make an impact as part of a company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• 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 <1224>, 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.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree