The Role:Moderna is seeking a Senior Manager, Bioanalytical and Molecular Laboratory to serve as a point of contact to supportquality control activities associated with development of the company's LNP-mRNA assetsfor the GcLP/GLP regulated laboratory.This position reports to the Associate Director of Bioanalytical and Molecular Assay group and is a part of Moderna's Clinical Assays and Supply Logistics group. Here's What You'll Do:Develop bioanalytical quality data standards [GLP/ICH/GCP/SOPs] across pre clinical and clinical studies (Phase I – III) in collaboration with laboratory operations team members/functions and BMA scientistsSupport QC review/approval of bioanalytical and molecular data test data for PK, immunogenicity and biomarkers generated through LC-MS, LBA and molecular methods. Support QC Review of the raw data generated in support of regulated studies, including but not limited to ELN entries, LIMS entries, supporting equipment records, etc.Responsible for gathering Quality data required to establish metrics and generate insights and day to day oversight of the Data Quality procedures in place.Evaluate performance, risks, and alignment with current regulatory expectations.Serve as a cross-functional lead for key initiatives relating to Quality metrics and reporting.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, Thermo Watson LIMS, JMP, and Veeva for clinical and preclinical projects.Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS) and execution of risk-based management solutionsCoordinate with internal and external groups to identify appropriate solutions to improve on clinical data analysisOperate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environmentHere's What You'll Bring to the Table:Bachelor's /Master's/PhD degree in Biology field or a related scientific discipline is strongly preferred5 to 10 years of relevant clinical laboratory experienceWell-versed in various bioanalytical and molecular techniques (e.g., immunoassays, cell based assays, mass spectroscopy, LC-MS, RT-qPCR and other methods for small and large molecules).Knowledge of Bioanalytical method validation/Immunogenicity guidance preferredKnowledge of data management tools, and data integrity requirements such as with QC review of LIMS/ELN system, CDISC and SEND data formatsPrevious experience in working in CAP/ CLIA, GLP regulated laboratory highly preferredWorking knowledge of quality systems and regulatory requirements (21 CRF Part 11/58)Previous experience in lab management and digital automation are preferred.Ability to oversee multiple aspects of the operationsAttention to detail, organizational ability, judgement, and good communication skillsModerna 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-KF1-
