Sr. Research Associate, Clinical Biomarker Laboratory

ModernaTX • Norwood, MA

4d • Onsite

About The Position

Moderna is seeking an experienced and highly motivated Senior Research Associate to join the Clinical Biomarker Laboratory (CBL) Immunoassay and Cell Based Assay group. This laboratory-based role will support the development, qualification, validation, transfer, and clinical implementation of cell-based assays, virus neutralization/functional antibody assays, and ligand-binding assays (LBAs) used to characterize vaccine-induced immune responses and support clinical vaccine development programs, while also contributing to biomarker and immunogenicity testing across Moderna's infectious disease, oncology, and autoimmune disease portfolio. The successful candidate will bring strong hands-on experience with mammalian cell culture, cell-based functional assays, and immunoassays and will be expected to independently execute assay development and optimization experiments, qualification/validation studies, clinical sample testing, data analysis, troubleshooting, and compliant documentation in a regulated clinical laboratory environment. Direct experience with virus neutralization or other functional antibody assays is preferred, including cell culture-based neutralization assays, reporter-based or pseudovirus neutralization platforms, and/or hemagglutination inhibition (HAI) assays. Experience with ligand-binding platforms such as ELISA or electrochemiluminescence-based assays is also highly desirable. The Senior Research Associate will work closely with the clinical Biomarker Laboratory Immuno-Assay Lead, and also with biostatisticians, Quality/ Compliance partners, and other cross-functional stakeholders to deliver high-quality, traceable, and regulatory-compliant bioanalytical data supporting Vaccine clinical development programs.

Requirements

• Bachelor's / Master’s/ PhD degree in Pharmaceutical Sciences or related industry with strong background in quality data analytics
• 2 to 5 years of relevant clinical laboratory experience in pharmaceutical industry or CROs
• Experience generating, reviewing, and documenting regulated clinical bioanalytical data in accordance with applicable GxP/GcLP expectations, data integrity principles, SOPs, and quality systems.
• Working knowledge of bioanalytical method development and validation principles for clinical immunogenicity assays, including accuracy/ precision, sensitivity, specificity/ selectivity, robustness, cut-point or titer-related considerations as applicable, and predefined acceptance criteria.
• Strong practical background in mammalian cell culture and functional assay execution, with demonstrated ability to recognize and troubleshoot cell-related, reagent-related, and assay-related sources of variability.
• Demonstrated hands-on experience developing, optimizing, qualifying, validating, and/or executing cell-based bioassays in support of vaccine, immunogenicity, or infectious disease programs.
• Knowledge in various lab-based techniques such as immunoassays, cell-based assays, and other platforms for the investigation of biomarkers in clinical phase studies.
• Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.).
• Attention to detail, organizational ability, judgement, team player attitude and effective communication skills.
• Demonstrated ability of multi-tasking.

Nice To Haves

• Direct experience with virus neutralization or other functional antibody assays is preferred, including cell culture-based neutralization assays, reporter-based or pseudovirus neutralization platforms, and/or hemagglutination inhibition (HAI) assays.
• Experience with ligand-binding platforms such as ELISA or electrochemiluminescence-based assays is also highly desirable.
• Experience working with critical reagents, reference standards, positive/negative controls, cell banks, assay system suitability criteria, and reagent or assay bridging studies is preferred.
• Hands-on experience with ligand-binding immunoassays used for clinical immunogenicity or biomarker testing, including ELISA and/or electrochemiluminescence platforms such as MSD, is highly desirable.
• Hands-on experience with virus neutralization or functional antibody assays is strongly preferred; experience may include pseudovirus neutralization, reporter-based neutralization, live-virus neutralization in an appropriately controlled environment, HAI, or other functional antibody platforms.
• Knowledge of Bioanalytical method validation for Industry is preferred.
• Knowledge of data management tools, and data integrity requirements such as with QC review of LIMS/ ELN/ LES system, RYZE, CDISC standard and data collection formats.
• Prior experience in Developing and maintaining study-specific data management documentation, Data Management Plan, and Data Cleaning Plan documentation is preferred.
• Previous experience in working in GxP or CAP/ CLIA, GLP regulated laboratory is highly preferred.
• Previous experience in Lab management and Digital Automation is.
• Proficiency with statistical analysis methodologies is a plus.

Responsibilities

• Contribute to preparation and review of assay methods, protocols, qualification/validation plans and reports, batch records, technical reports, and controlled documentation required for regulated clinical bioanalysis.
• Analyze assay data, identify trends or sources of variability, document investigations and troubleshooting, and partner with assay leads and biostatisticians to support scientifically sound interpretation of assay performance and clinical immunogenicity data.
• Perform clinical sample testing with strong attention to chain of custody, sample handling, plate maps/worklists, assay controls, repeat testing rules, data traceability, and timely delivery of high-quality results to support clinical study milestones.
• Execute ligand-binding assays for vaccine immunogenicity and biomarker endpoints, including preparation and qualification of critical reagents and controls, plate-based assay execution, curve fitting and data review, and evaluation of assay performance against predefined acceptance criteria.
• Run neutralization assays and related functional antibody assays using established viral, pseudoviral, reporter-based, or other qualified assay platforms; assess assay controls and system suitability, calculate and review neutralizing antibody readouts/titers, and troubleshoot assay performance when acceptance criteria are not met.
• Maintain and use mammalian cell culture systems required for functional bioassays, including cell expansion, passage, cell banking support, assay readiness assessment, and monitoring of cell performance in accordance with established procedures and biosafety requirements.
• Independently execute and support development, optimization, qualification, validation, transfer, and routine clinical testing of cell-based assays, virus neutralization/functional antibody assays, and ligand-binding assays supporting vaccine development programs.
• Develop analytical quality data standards related to GLP/ ICH/ GCP in accordance with existing SOPs across clinical studies and in collaboration with Laboratory Operations lead and scientific leaders at CBL.
• Responsible for gathering Quality data required to establish metrics and generate insights and daily oversight of the Data Quality procedures in place.
• Support assay transfer and implementation across internal laboratories and external partners/ CROs, including technical training, method comparability, reagent readiness, and resolution of assay performance issues.
• Evaluate performance, risks, and alignment with current regulatory expectations.
• Participate into cross-functional key initiatives relating to Quality metrics and reporting.
• Collaborate with study personnel to ensure documentation review and corrections are complete throughout regulated studies and during QA audits.
• Act as Document Coordinator to track version changes of controlled documents, and distribution and training of new versions.
• Assist with maintaining the master schedule.
• Assist widevelopment or revisions of SOPs
• Lead Quality analytics processes and develops analysis procedure and reporting mechanisms to improve GxP compliance.
• Support data peer-review generated from biomarker assays through analytical and cell-based assay methods.
• Participate in review of protocols, methods, reports, batch records and related GLP/GcLP source documents to actively manage data and documents by using various software like Excel, LabVantage LIMS (Laboratory Information Management System) database for clinical phase studies.
• Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS) and execution of risk-based management solutions.
• Collaborate with internal and external groups to identify appropriate solutions to improve on clinical data analysis and Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.

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