Scientist, Analytical Development

Job description

The Role In this role, you will develop, optimize, and implement sequencing-based analytical methods supporting mRNA-based vaccines, therapeutics, and emerging nucleic-acid modalities at various stages within Analytical Development. You will apply strong molecular biology and sequencing expertise across next-generation sequencing (NGS), Oxford Nanopore Technologies (ONT) long-read sequencing, Illumina short-read sequencing, and related emerging technologies to characterize DNA, RNA, and mRNA products, assess critical quality attributes, confirm identity and sequence integrity, and detect product- and process-related impurities and variants. Success in this role requires hands-on scientific strength in assay and workflow development, a strong understanding of sequencing fundamentals and nucleic-acid sample preparation, effective partnership with Moderna bioinformatics, and cross-functional collaboration. You will own defined method-development workstreams, build robust and phase-appropriate analytical procedures, and help establish sequencing platform methods that can be leveraged across programs and ultimately transitioned into the broader analytical and Quality Control network. Here’s What You’ll Do Design, develop, optimize, and execute sequencing-based analytical methods using Oxford Nanopore Technologies (ONT), Illumina, and other appropriate next-generation or long-read sequencing platforms for early- and clinical-stage DNA, RNA, and mRNA products. Develop fit-for-purpose sequencing methods to assess relevant product quality attributes, including identity, sequence confirmation, sequence integrity, impurity profiles, structural variants, transcript heterogeneity, and other attributes requiring nucleotide-level or molecule-level resolution. Translate product and control-strategy needs into phase-appropriate assay performance requirements, selecting appropriate sequencing modality, sample-preparation and library-preparation approaches, controls, reference materials, run designs, and analysis strategies for the intended use of the method. Systematically optimize critical assay parameters including nucleic-acid extraction and handling, reverse transcription or cDNA generation where applicable, PCR or targeted enrichment, library preparation, input amount, sequencing chemistry, run conditions, basecalling, and data-processing settings to achieve robust analytical performance. Apply Design of Experiments where appropriate to understand assay robustness, establish specificity, accuracy, precision, linearity, range, detection capability, and other relevant performance characteristics, and identify scientifically justified operating ranges and controls. Develop and implement ONT workflows including direct RNA sequencing, cDNA sequencing, targeted sequencing, and other long-read approaches, while evaluating complementary short-read methods when they provide meaningful analytical value. Generate high-quality sequencing datasets and partner closely with bioinformatics scientists to establish fit-for-purpose analysis pipelines, quality metrics, variant-calling or sequence-comparison approaches, data-review standards, and reporting strategies. Troubleshoot complex sequencing and molecular-biology challenges and investigate unexpected analytical observations by integrating wet-lab, sequencing, bioinformatics, and orthogonal analytical data to develop scientifically sound hypotheses and solutions. Drive platform implementation by identifying opportunities to standardize and reuse sequencing assays, library-preparation workflows, controls, and analysis approaches across related products and modalities, reducing unnecessary method proliferation and accelerating future program development. Partner closely with Analytical Product Leads (APLs), Analytical Sciences, Product Characterization, Process Development, Research, Manufacturing Sciences, and other CMC partners to connect sequencing-method development with product understanding, process-development needs, comparability assessments, and evolving analytical control strategies. Collaborate with Analytical Technical Operations, Analytical Sciences & Technology (AST), Quality Control, Quality Assurance, Regulatory Affairs, and Bbioinformatics partners to support method pre-qualification, qualification or validation, technical transfer, downstream implementation, and regulatory documentation; author and review methods, protocols, development reports, SOPs, technical summaries, and supporting documentation. Here’s What You’ll Need (Basic Qualifications) Ph.D. in Molecular Biology, Analytical Chemistry, Biochemistry, Genetics, Biotechnology, Pharmaceutical Sciences, 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 with next-generation sequencing technologies, including Illumina and/or Oxford Nanopore sequencing, together with molecular biology and nucleic-acid sample-preparation experience, is required. Here’s What You’ll Bring to the Table (Preferred Qualifications) Strong scientific foundation in next-generation and long-read sequencing, including sequencing chemistry, read-generation principles, sources of bias and error, assay controls, run-quality metrics, and the practical factors that drive analytical method performance and robustness. Demonstrated hands-on experience developing and optimizing Illumina and/or Oxford Nanopore Technologies (ONT) sequencing methods; experience with direct RNA, cDNA, targeted, amplicon, or other application-relevant sequencing workflows is highly desirable. Strong expertise in molecular biology techniques including RNA and DNA handling, nucleic-acid purification, reverse transcription, PCR/qPCR, cloning or amplification strategies where appropriate, and sequencing library preparation. Experience developing sequencing-based methods for identity testing, sequence confirmation, impurity characterization, structural-variant detection, transcript or construct characterization, and/or sequencing-enabled multi-attribute analytical approaches. Experience supporting analytical development for mRNA, RNA, plasmid DNA, nucleic-acid therapeutics, vaccines, gene-editing or gene-therapy materials, or other advanced therapeutic modalities is preferred. Working knowledge of bioinformatics and sequencing data analysis sufficient to partner effectively with computational scientists on basecalling, alignment, consensus generation, variant detection, quality metrics, data visualization, and fit-for-purpose reporting. Demonstrated ability to independently plan and execute assay-development experiments, interpret complex molecular and sequencing data, troubleshoot technical issues, and make data-driven recommendations within defined scientific objectives. Understanding of phase-appropriate analytical development and method lifecycle principles, including method development, robustness assessment, pre-qualification or qualification, technical transfer, validation, continued performance monitoring, and continuous improvement. Familiarity with science- and risk-based analytical development principles, including ICH Q14/Q2 concepts, analytical target profile or intended-use thinking, structured experimental design, and establishment of appropriate assay controls, acceptance criteria, and system- or run-suitability metrics. Experience developing platform methods or implementing standardized sequencing, molecular-biology, or data-analysis approaches across multiple products, programs, laboratories, or modalities is highly desirable. Experience with sequencing instrumentation and associated software ecosystems, laboratory automation, liquid handling, LIMS or sample-tracking systems, and automated or reproducible data-processing workflows is a plus. Strong scientific curiosity, written and verbal communication skills, and demonstrated ability to collaborate effectively across Analytical