Scientist, Analytical Development

Job description

The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. In this individual contributor role, you will develop, optimize, and implement advanced analytical methods that support clinical and commercial QC release testing, product characterization, process development, and broader analytical needs across mRNA-based vaccines, therapeutics, and emerging modalities. You will combine deep hands-on expertise across electrophoretic, microfluidic, automated biomolecule-analysis, immuno-based, and emerging technologies with rigorous experimental design, data interpretation, and phase-appropriate analytical development principles to solve complex product-quality and control-strategy challenges. Owning defined method-development workstreams from scientific concept through downstream implementation, you will help establish robust, fit-for-purpose and next-generation platform methods that can scale across programs and transition effectively into Moderna’s broader analytical and Quality Control network. Here’s What You’ll Do Design, develop, optimize, and execute analytical methods supporting drug substance, drug product, and process intermediates across early development, clinical, and commercial programs. Develop and evaluate fit-for-purpose electrophoretic, microfluidic, and automated separation-based methods, including capillary electrophoresis, CE-SDS, cIEF/icIEF, microchip electrophoresis, automated gel-based methods, and related technologies where scientifically appropriate. Develop and optimize automated biomolecule and immuno-based analytical methods, where appropriate, using capillary-based immunoassays, automated Western-type platforms, ligand-binding approaches, and related quantitative biomolecular-analysis technologies. Evaluate and implement next-generation analytical platforms, including microfluidic and lab-on-a-chip technologies, automated electrophoretic analysis systems, and other emerging technologies that improve robustness, throughput, automation readiness, scalability, or ease of deployment. Translate product knowledge, critical quality attributes, process-development questions, and control-strategy needs into phase-appropriate analytical requirements and clearly defined method intended use. Select appropriate analytical technologies, sample-preparation strategies, detection approaches, controls, and data-analysis methods based on the scientific question and stage of development. Apply science- and risk-based analytical development principles, including analytical target profile or intended-use thinking, risk assessment, structured experimentation, Design of Experiments, and ICH Q14/Q2(R2) concepts where appropriate. Systematically optimize critical method parameters and evaluate analytical performance characteristics including specificity, accuracy, precision, linearity, range, detection capability, robustness, and system suitability to establish scientifically justified operating ranges and controls. Independently troubleshoot complex analytical challenges and unexpected observations by integrating method-development data, product knowledge, orthogonal analytical results, and scientific literature to develop and test scientifically sound hypotheses and solutions. Identify opportunities to establish analytical platform methods that can be standardized, harmonized, and reused across related products, programs, laboratories, or modalities, reducing unnecessary method proliferation and accelerating future development. Evaluate emerging analytical technologies and lead or support proof-of-concept studies to determine their suitability for release testing, product characterization, process-development support, or other intended uses across development and Quality Control networks. Support lifecycle management and modernization of established analytical procedures, including assessment of method performance, troubleshooting emerging issues, and identifying opportunities to improve robustness, automation, scalability, or replace existing approaches with more suitable platform methods where scientifically justified. Author and review analytical method procedures, development reports, impact assessments, method assessments, and supporting regulatory documentation. Collaborate with Analytical Sciences & Technology (AS&T), Quality Control, Analytical Sciences, Analytical Technical Operations, and other partners to support method pre-qualification, qualification or validation, technical transfer, downstream implementation, troubleshooting, and lifecycle management, designing methods from the outset with future routine and QC use in mind. Partner closely with Analytical Product Leads (APLs), Process Development, Product Characterization, Research, Manufacturing, and other CMC partners to connect analytical method development with product understanding, process-development needs, comparability assessments, investigations, and evolving analytical control strategies across early, clinical, and commercial programs. Partner closely with Applied Technology, Digital, and Quantitative Science to incorporate automation, miniaturization, and high-throughput concepts into method development where appropriate, including automated sample preparation, liquid handling, plate-based workflows, and reproducible data-processing approaches. Bring strong experimental design and data-interpretation capabilities to method-development workstreams, applying a solid understanding of phase-appropriate analytical development and analytical procedure lifecycle principles to deliver methods that are robust and fit for their intended use. Own defined analytical method-development workstreams and translate complex analytical needs into practical, scientifically rigorous procedures that can ultimately be deployed across the broader analytical and Quality Control network. Explore opportunities to work closely with emerging Generative AI tools and digitally enabled scientific workflows to accelerate analytical knowledge synthesis, experimental planning, data interrogation, troubleshooting, documentation, and method-development decision making, while maintaining appropriate scientific and quality oversight. The key Moderna Mindsets you’ll need to succeed in the role: “We prioritize the platform over any single solution.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Need (Basic Qualifications) Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, Biotechnology, Pharmaceutical Sciences, Bioengineering, Chemical Engineering, or a related field with 0–2 years of relevant experience; or M.S. with 8+ years; or B.S./B.A. with 10+ years of relevant industry experience. Strong hands-on experience in analytical method development, including experience with at least one relevant platform such as molecular assays, electrophoretic or microfluidic methods, immuno-based assays, or related analytical technologies, is required. Here’s What You’ll Bring to the Table (Preferred Qualifications) Strong scientific foundation in analytical method development, including systematic method optimization, Design of Experiment, troubleshooting, robustness assessment, and interpretation of complex analytical data. Experience with one or more electrophoretic or microfluidic analytical technologies, such as capillary electrophoresis, CE-SDS, cIEF/icIEF, microchip electrophoresis, automated gel electrophoresis, LabChip-type platforms, or related miniaturized separa