Principal Scientist, Bioanalytical and Molecular Assay

Overview:Moderna is seeking an experienced Principal Scientist to join our Bioanalytical and Molecular Assays team. This role involves supporting regulated non-clinical studies and clinical trials, specifically focusing on the bioanalytical assessment of cell therapies and the characterization of humoral and cellular immunogenicity of mRNA-LNP therapeutics.Key Responsibilities:Design and execute phase-appropriate clinical bioanalytical strategies, including quantitation and characterization of engineered cell therapies and immunogenicity evaluations (ADA, APA, nAb, ELISpot) of mRNA-LNP therapeutics. This includes method development, validation, and sample testing under GLP/GcLP regulations.Lead a team to ensure timely assay development, regulatory-compliant qualification or validation of assays, and troubleshooting of any internal or external CRO partner issues.Develop cell-based nAb assays, cell therapy PD assays (Flow Cytometry), immune cell activation assays (ELISpot), APA, and/or PD assays using technologies such as ELISA, MSD, Gyros, multiplex LBAs, and Luminex-based protein assays.Support and facilitate method development to support Moderna’s portfolio, including analytical equipment procurement/qualifications and preparation and maintenance of SOPs.Hands-on knowledge of various Laboratory Information Management Systems such as Thermo Watson, LabVantage, ELN etc. Knowledge of AI application in regulated bioanalysis is preferred.Deep knowledge of government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.Qualifications:Ph.D. in Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related fields with a minimum of 9+ years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.Preferred experience with RNA, biologics, and cell therapy. Expert knowledge of cell-based assays, including flow cytometry and ELISpot or similar methodologies for pre-clinical and clinical assays, is required.Ability to effectively communicate scientific concepts, program objectives, and data analysis within a matrix environment.Strong understanding of GLP requirements and current industry trends and regulatory expectations associated with bioanalytical science. Deep knowledge of regulatory guidances such as BMV, M10 and similar.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.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit

modernatx.com/careers

to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna 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 proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 law.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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

leavesandaccommodations@modernatx.com . (EEO/AAP Employer)

#J-18808-Ljbffr