Sr. Scientist, Bioanalytical and Molecular Assays
2 weeks ago
The Role:
Moderna's Bioanalytical and Molecular Assay team is looking for a Sr. Scientist with strong hands-on experience in the regulated bioanalytical LC-MS/MS area within GLP/GcLP regulations. The individual should have recent experiences in the processing and analysis of a wide range of molecules such as lipids, proteins, peptides, oligos, etc. The role will support method development and validation for the clinical development of candidates applying cutting-edge LC/MS techniques toward mechanistic and quantitative assessment of Moderna's mRNA-LNP therapeutics. The candidate must thrive in a scientifically stimulating, fast-paced environment with high expectations. Independent method development, validation, ability to troubleshoot, collaborate with cross-functional teams, respect for peers/colleagues, excellent work ethic, and setting the bar high are key values to thrive in our Team.
Here's What You'll Do:
Lead regulated bioanalytical projects from method development to validation and sample analysis in order to support various Moderna Clinical Programsunder GLP/GcLP compliance. Develop, qualify, and/or validate LC/MS methods for the quantitation of various types of biomolecules, particularly lipids, proteins (peptides), amino acids, and Oligos Evaluate and review raw data, assay validation reports, sample analysis reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific). Support nonclinical studies to evaluate PK/TK, safety, and efficacy of Moderna's drug candidatesas needed Support lab related activities using current LIMS software and use of AI as appropriate Perform method transfer to internal and external stakeholders for qualification/validation Review and author SOPs, relevant protocols, and reports and interact with QAs Work closely with colleagues in clinical development organization as well as other cross-functional groups Independently serve as an SME representing the BMA team, to support colleagues, from guiding experimental design to analysis and presentation of results Provide mass spectrometry support to scientists in Nonclinical, Platform, and other groups Mentor and train the junior members of the group Here's What You'll Bring to the Table: Ph.D. with least 4+ years or MS with7+years of demonstrated hands-on experience with the development and validation of bioanalytical methods using LC-MS (QQQ and or QTRAPs) Hands-on experience with the development of sample preparation/extraction techniques for various analytes from biological matrices such as SPE, LLE, protein precipitation, IP-LCMS/MS In-depth knowledge of US, EU regulations, M10 regulations and ICH guidelines. Assist in writing regulatory submissions and in responding to regulatory queries when needed. Experience with Watson LIMS design and data management are preferred Experience with metabolite profiling, identification, and characterization of metabolites using High-resolution mass spectrometry (HRMS) Met ID of small molecules and lipids are preferred. Ability to develop and implement methods for high throughput or (semi-)automated data analysisis preferred. Willingness to learn new concepts and challenge boundaries; adaptability to change Organization and attention to detail; ability to handle multiple projects in a fast-paced environment Strong interpersonal skills with an eagerness to work with and support colleagues in other departments Proven ability to develop and work independently and to collaborate cross-functionally to accomplish goals in a timely manner CROs management experience is preferred Moderna 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 parents 401k 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 Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 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. Were 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)
-
-
Sr. Statistician, CMC Quantitative Sciences
2 weeks ago
Norwood, Massachusetts, United States Moderna Full timeSr. Statistician, CMC Quantitative Sciences page is loaded Sr. Statistician, CMC Quantitative Sciences Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted 4 Days Ago job requisition id R15859 The RoleIn this role, you will provide strategic statistical guidance and leadership to project teams. Working...
-
Sr. Engineer I, Automated Systems Engineering
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna is looking for a Senior Engineer I to join the Automated Systems Engineering team at our site in Norwood MA. The person in this role will work on the development, demonstration, and delivery of projects related to automated systems, help with documentation, and act as an SME in cross-functional teams. This role will have a significant impact...
-
Scientist, Analytical Development
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna is seeking a talented and motivated Scientist with a strong background in Analytical Chemistry. This individual will primarily work with analytical and process teams on stability studies for early to late phase mRNA-Lipid Nanoparticles (LNPs) based vaccines and therapeutics. The responsibilities will include participating in stability study...
-
quality control, bioassay data reviewer
2 weeks ago
Norwood, Massachusetts, United States Randstad US Full timequality control, bioassay data reviewer. norwood , massachusetts posted march 27, 2024job detailssummary $45 - $50 per hour contract bachelor degree category life, physical, and social science occupations reference47779job detailsjob summary:As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Clinical Biomarker Laboratory group at Moderna is seeking a Senior Manager to serve as a point of contact to support quality control activities associated with the growth of clinical phase studies run within the GCLP/ GLP regulated biomarker laboratory. The Data QC senior manager will provide quality support and guidance related to laboratory...
-
Norwood, Massachusetts, United States Moderna Theraputics Full timeThe Role:The Clinical Biomarker Laboratory group at Moderna is seeking a Senior Manager to serve as a point of contact to support quality control activities associated with the growth of clinical phase studies run within the GCLP/ GLP regulated biomarker laboratory. The Data QC senior manager will provide quality support and guidance related to laboratory...
-
Sr Engineer I, Systems Integration
2 weeks ago
Norwood, Massachusetts, United States Moderna Full timeSr Engineer I, Systems Integration page is loaded Sr Engineer I, Systems Integration Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted 7 Days Ago job requisition id R14374 The Role:Moderna is seeking an Sr Engineer I for a position in the Systems Integration (SI) team, at the Moderna manufacturing site in...
-
Sr. Director, Technical Documentation
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModernas Technical Development organization is looking for a Sr. Director, Technical Documentation with significant experience in creating and revising Chemistry, Manufacturing, and Controls (CMC) source documents for global regulatory submissions of biotech products. The Sr. Director will drive the development of consistent, high-quality...
-
Sr Engineer I, Systems Integration
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Sr Engineer I for a position in the Systems Integration (SI) team, at the Moderna manufacturing site in Norwood, MA to drive the advancement of our next generation integrated hardware and digital systems. Reporting to the Principal Engineer, Applied Technologies, the individual in this role will focus on leading the design,...
-
Research Associate, Process Development
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. Were seeking a highly skilled and motivated Research Associate to reside in Modernas Technical Development organization in Norwood, MA. This is a lab-based role that will support the early phase process development of Modernas mRNA-based medicines to enable our...
-
Sr. Statistician, CMC Quantitative Sciences
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will provide strategic statistical guidance and leadership to project teams. Working collaboratively with cross-functional teams, you will partner with colleagues in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research. Your understanding of these domains will be essential in identifying the...
-
Sr. Data Scientist, CMC Data Science
4 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will be part of a vibrant team responsible for providing data science and analytics support for GMP and Development Production operations at our Norwood site and global partners. You will contribute to process science data centric activities which support the Operations, Quality, Manufacturing Science and Technology, and Technical...
-
Research Associate, Process Development
2 weeks ago
Norwood, Massachusetts, United States Moderna Full timeResearch Associate, Process Development page is loaded Research Associate, Process Development Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted 9 Days Ago job requisition id R14693 The Role:Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. Were seeking a highly...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will be accountable for defining the CMC lifecycle road map and guiding the raw materials through key lifecycle milestones such as definition of specifications, process and method development, and qualification for custom small molecules. The Senior Manager will lead a cross functional team of scientists and engineers while acting...
-
Sr. Engineer I
2 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna is seeking a highly skilled and motivated Senior Engineer I or Scientist to join our Drug Product Development (DPD) team in Norwood, MA. To support Modernas exciting pipeline of products, the DPD team works to develop, characterize, and implement robust clinical/commercial manufacturing processes. From pre-clinical through commercialization,...
-
Sr. Engineer I, Drug Product Development
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a highly skilled and motivated Scientist or Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA. To support Modernas exciting pipeline of products, the DPD team works to develop, characterize, and implement robust clinical/commercial manufacturing processes. From pre-clinical through commercialization,...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleTechnical Development seeks a Senior Manager who will be responsible for translating our strategies into execution. The Technical Development organization is comprised of scientists, engineers, and problem solvers that develop and implement the most innovative, advanced, and robust platform manufacturing processes and analytical technologies to...
-
Sr. Engineer II, Drug Product Development
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:This position is part of Modernas Drug Product Development team responsible for ensuring the translation of mRNA technology into successful dosage form and commercial product from a pharmaceutical sciences and engineering perspective. The incumbent will also provide technical leadership and mentoring to the Drug Product Development (DPD) group,...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna is seeking a highly skilled and motivated Scientist or Engineer to join our Respiratory Drug Product Development (DPD) team in Norwood, MA. To support Modernas exciting pipeline of products, the DPD team works to develop, characterize, and implement robust clinical/commercial manufacturing processes. From pre-clinical through...
-
Norwood, Massachusetts, United States Moderna Full timeDirector, Drug Product Operations, Formulation and Filling page is loaded Director, Drug Product Operations, Formulation and Filling Apply locations Norwood, Massachusetts Drug Manufacturing time type Full time posted on Posted 2 Days Ago job requisition id R15579 The RoleAs the Director of Drug Product Operations (Formulation and Filling) at Moderna, you...
