Sr. Research Associate, Clinical Biomarker Laboratory

The Role:

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 Modernas 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.

Heres What Youll Do:

• 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.

Heres What Youll Bring to the Table:

• Bachelors / Masters/ 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.

• 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.

• 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.

• 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 Microsoft Office Suite (Outlook Excel Word etc.). Proficiency with statistical analysis methodologies is a plus.

• Attention to detail organizational ability judgement team player attitude and effective communication skills.

• Demonstrated ability of multi-tasking.

• Limited travel to visit other group at Moderna including our main facility in Cambridge MA may be expected.

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. Thats why our benefits and well-being resources are designed to support youat 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 $74000.00 - $118400.00. 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 individuals position within the salary range will be based on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens U.S. lawful permanent residents asylees or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered contingent on the companys ability to obtain any required export control license.

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