The Role:Moderna is seeking a talented, experienced and motivated Senior Research Associate to join the Clinical Immuno-Assay group to serve as an analyst for the biomarker assay development, qualification/ validation to support programs across multiple therapeutic areas. The candidate is expected toindependently execute experiments and conduct clinical samples analysis in a regulated laboratory at Moderna.The candidate will have knowledge of best practices in bioanalytical assay procedures, and prior experience in running assay validation and conducting data acquisition on clinical specimen. In addition, the candidate may train junior team members when and where needed to perform analytical work and maintain clinical testing continuity. The ability to effectively communicate within a project team and with external partners is expected. The candidate will stay aware of the newest technology and critical reagents in his/ her field of expertise. The candidate should be a collaborative team member and an excellent communicator to support Moderna's portfolio needs.Thecandidatewill work closely with project team members to develop analytical methods and characterization tools in support of our clinical phase studies. The position will report to the Director of Immuno-Assay.Here's What You'll Do:Under the guidance of project lead, be responsible for the overall quality and integrity of assigned bioanalytical projects in support of clinical trials at ModernaAs a key analyst, conduct assay development, qualification/validation and sample analysis on a variety of platforms (ELISA, MSD, Ella, Hamilton…)Deliver high quality data within defined timelines and aligned to current industry expectationsReview and QC data, author bioanalytical reportsIdentify and resolve quality issues and report issues to upper managementMay serve as a Subject Matter Expert (SME) in a multifunctional project teamRepresent the bioanalytical function on project teams and present results, data interpretation, timelines etc. at project meetingsOccasionally the job may require overtime work or weekend shift as neededCoach and train junior staff within the labAssume assigned general laboratory responsibilities, e.g. safety coordinator, instrument/process/technology owner etcAlways ensure staff compliance with safety and regulatory guidelines. Maintain training recordsAttending technical conferences and exhibits as requiredHere's What You'll Bring to the Table:Bachelor or MSc with 2+ years' experience in bioanalysis or related field preferably in a regulated environment for biomarker analysisDemonstrated level of independenceFlexibility with changing priorities and urgent project requestsGood level of understanding and expertise in design and executing ligand binding based bioanalytical methodsKnowledge in best practices recommended by FDA, CLSI to conduct development, qualification and validation of assays (e.g. M10 Bioanalytical Method Validation)Good written, presentation and interpersonal communication skillsGood computational skills, preferably experienced with Word, Excel, Power Point, GraphPad PrismKnowledge of system software for data analysis: Softmax pro, Gen 5 and basic laboratory statisticsExperience with LIMS systemUnderstanding of current GLP or CAP/CLIA/ISO standardsPreferably experienced with Multiplex immunoassayPreferably experienced with bioanalytical assays for vaccine development and infectious diseasePreferably experienced with cell-based neutralization assayPreferably experienced with cell culture, ex vivo assays and cell isolation from tissuesModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince 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 peopleare 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.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.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 ****** . (EEO/AAP Employer) #LI-TR1-
