Scientist, Analytical Sciences and Technology

The Role Moderna is seeking an Individual that will provide technical leadership and execution support for analytical method lifecycle management across commercial and late-stage development programs. This role will be responsible for method transfer, validation, troubleshooting, investigations, and continuous improvement activities supporting Quality Control laboratories, manufacturing operations, and external testing partners. The Candidate will serve as a key technical resource across the analytical network, collaborating with Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and Contract Manufacturing Organizations (CMOs) to ensure robust analytical performance, compliance, and inspection readiness. The successful candidate will leverage scientific expertise to support product lifecycle management, drive technical solutions, and ensure reliable execution of analytical testing strategies. Here's What You’ll Do Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories. Provide technical expertise for method performance monitoring and lifecycle management activities. Evaluate analytical method suitability and identify opportunities for continuous improvement. Technical Support & Troubleshooting Serve as a subject matter expert for analytical methods and testing processes. Support troubleshooting of analytical issues impacting laboratory operations, manufacturing, and product disposition. Collaborate cross-functionally to identify root causes and implement effective corrective actions. Investigations & Data Review Support laboratory investigations, out-of-specification (OOS), out-of-trend (OOT), and atypical result assessments. Perform scientific data analysis to identify trends, risks, and opportunities for process improvement. Contribute to development and implementation of CAPAs to address analytical and operational issues. Documentation & Compliance Author, review, and approve technical documents including protocols, reports, methods, specifications, and standard operating procedures (SOPs). Ensure documentation is accurate, compliant, and inspection-ready. Support regulatory submissions, health authority inspections, and internal audits as required. QC Network & External Partner Support Collaborate with QC laboratories and external testing partners to ensure successful method implementation and execution. Provide technical oversight and support for analytical activities conducted at CMOs and contract testing laboratories. Support network harmonization efforts and best-practice sharing across sites. Data Trending & Continuous Improvement Analyze analytical performance metrics and trending data to drive informed decision-making. Support development and implementation of process improvements that enhance efficiency, compliance, and robustness. Contribute to digital and data-driven initiatives supporting analytical operations. Here’s What You’ll Need (Basic Qualifications) Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 5+ years of relevant industry experience; OR Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 3+ years of relevant industry experience; OR PhD in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 0–2 years of relevant industry experience. Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management activities in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment. Experience authoring and reviewing technical documents, including protocols, reports, specifications, test methods, investigations, and standard operating procedures (SOPs). Working knowledge of GMP regulations, data integrity principles, and pharmaceutical quality systems. Experience supporting laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), deviation, or atypical result assessments. Demonstrated ability to analyze scientific data, identify trends, and apply scientific judgment to solve technical problems. Experience working effectively in cross-functional teams with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and/or external partners. Here’s What You’ll Bring to the Table (Preferred Qualifications) Strong understanding of analytical method validation, transfer, qualification, verification, and lifecycle management principles, including application of risk-based and phase-appropriate strategies. Hands-on experience with chromatographic, spectroscopic, molecular, lipid-based, vaccine, biologics, or biochemical analytical techniques. Knowledge of applicable regulatory and compendial expectations, including ICH, USP, FDA, EMA, and other global health authority requirements. Experience leading or substantially contributing to investigations, CAPAs, deviation management, change controls, or analytical troubleshooting activities. Experience working with external manufacturing organizations, contract testing laboratories, or other third-party testing partners. Experience supporting analytical control strategies, method readiness, product lifecycle changes, or regulatory filing activities. Ability to communicate complex technical topics clearly to cross-functional stakeholders, including Quality, Manufacturing, Regulatory, Technical Development, and senior leadership audiences. Demonstrated ability to operate effectively in a matrixed, fast-paced, and evolving technical environment. Competency Scientific problem solving and critical thinking Technical leadership and collaboration Strong data analysis and