Scientist, Analytical Development

Job description

The Role In this role, you will develop mechanism-driven bioassays for early-stage mRNA-based vaccines and therapeutics within Analytical Development. You will work closely with Research from the earliest stages of product development to translate product biology, mechanism of action, and exploratory Research assays into scientifically relevant, robust, and phase-appropriate analytical methods. Success in this role requires strong hands-on expertise in cell biology and bioassay development, scientific curiosity, and effective collaboration across Research and Technical Development. You will own defined assay-development workstreams, generate proof-of-concept data, improve assay performance and reproducibility, and help mature promising assays toward future CMC and Quality Control applications. Here’s What You’ll Do Partner closely with Research scientists early in the program lifecycle to understand target biology, product mechanism of action, therapeutic hypotheses, and available assays, reagents, and experimental models. Design, develop, optimize, and execute cell-based potency and biological activity assays supporting emerging mRNA-based vaccines, therapeutics, and new modalities. Translate exploratory Research assays into robust, reproducible, CMC-amenable methods by evaluating biological relevance, assay format, sensitivity, dynamic range, precision, robustness, throughput, and suitability for continued development and eventual QC transfer. Generate proof-of-concept data with relevant drug product and other representative materials to demonstrate biological activity and establish the relationship between assay response and intended mechanism of action. Plan and execute experiments to understand assay performance, sources of variability, and potential failure modes; analyze data, formulate hypotheses, troubleshoot technical issues, and recommend experimental next steps. Collaborate with Research and Development partners to identify, engineer, characterize, and maintain appropriate cell systems and critical biological reagents needed for sustainable bioassay development. Apply complementary analytical approaches such as protein-expression assays, ligand-binding methods, flow cytometry, molecular biology techniques, and other orthogonal technologies to strengthen mechanistic understanding and assay relevance. Partner with Analytical Product Leads (APLs), Process Development, Research, AS&T, QC, Applied Technologies, Quality, and other functions to align assay-development activities with program priorities and downstream analytical requirements. Advance assays from proof-of-concept through method development and pre-qualification, including preparation of methods, protocols, reports, development summaries, and supporting documentation; contribute to downstream qualification, transfer, and lifecycle activities as appropriate. Identify opportunities to leverage platform or semi-platform bioassay approaches across related products and modalities, and evaluate new technologies or automation approaches that improve assay robustness, biological relevance, throughput, or development speed. Communicate experimental results, scientific conclusions, risks, and recommendations clearly to technical and cross-functional stakeholders while maintaining high standards for laboratory safety, data integrity, and documentation. Here’s What You’ll Need (Basic Qualifications) Ph.D. in Cell Biology, Molecular Biology, Immunology, Biochemistry, Bioengineering, 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. Hands-on experience with mammalian cell culture and development or optimization of cell-based assays is required. Here’s What You’ll Bring to the Table (Preferred Qualifications) Hands-on experience in immunology and/or oncology research, including multiparameter flow cytometry and in vivo/ex vivo assays to evaluate immune function, mechanism of action, and/or anti-tumor activity Strong foundation in cell biology and demonstrated ability to translate biological mechanisms into meaningful functional assay designs. Experience developing cell-based potency, biological activity, reporter-gene, target-binding, or other mechanism-of-action-related bioassays. Experience working at the interface between Research/Discovery and Development, including adapting exploratory assays into more robust and reproducible analytical methods. Hands-on experience with relevant technologies such as reporter assays, flow cytometry, ELISA/MSD, ligand-binding assays, qPCR/ddPCR, protein-expression assays, imaging, or other cellular and molecular biology techniques. Experience with mammalian cell-line engineering, cell banking, or characterization and management of assay-critical cell systems and biological reagents is highly desirable. Ability to assess key assay performance characteristics including specificity, sensitivity, dynamic range, precision, variability, robustness, and fitness for intended use. Familiarity with quantitative analysis of bioassay data, including dose-response relationships, curve fitting, relative activity or potency measurements, and assessment of assay variability. Experience with mRNA, nucleic-acid therapeutics, lipid nanoparticles, vaccines, oncology, immunology, or other advanced therapeutic modalities is preferred. Understanding of phase-appropriate analytical method development and how methods progress from early Research through analytical development, pre-qualification, transfer, and eventual use in a regulated testing environment. Familiarity with critical quality attribute concepts, analytical control strategies, and regulatory expectations for biological activity or potency assays is a plus. Strong scientific curiosity, problem-solving ability, written and verbal communication skills, and demonstrated ability to collaborate effectively across multidisciplinary teams. Self-motivated and organized, with the ability to manage multiple experimental priorities while maintaining scientific rigor and high-quality documentation, and a desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Our Working Model As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. 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 The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifica