The 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 designs, authoring study protocols, reports, and conducting data mining/trending and statistical analysis generated with analytical methods for mRNA drug substance and lipid nanoparticle drug products, as well as for lipids and raw materials. The individual is expected to work in a highly collaborative, cross functional team environment, and interface with different departments and technical and strategy teams. The candidate must thrive in a fast-paced environment with high expectations. Integrity, ability to share experimental issues and troubleshoot, curiosity, collaborative spirit, respect for people, exemplary work ethic and setting the bar high are key values to thrive in our Team. This role is non-laboratory based.Here's What You'll DoWork closely Analytical Program Leads to support stability study designs based on practical understanding of ICH stability guidelinesDevelop and author stability study plans, protocols, and reports to support development of early to late phase mRNA-LNP vaccines and therapeutics programsWork closely with CMC statistical team on stability data analysis and perform data trendingProvide technical leadership to support investigations of out of specification or out of trend analytical results in collaboration with analytical technical operations and quality organization.Generate high quality documentation to support regulatory submissions and internal communications.Serve as a subject matter expert in stability to support analytical development, process development, analytical science and technology, manufacturing, quality, supply chain and regulatory teams.Additional duties as may be assigned from time to timeHere's What You'll Need (Basic Qualifications)MS with 5-8 years or BS with 8-10 years of biotech or pharmaceutical industry experience in analytical development.Strong background in chromatographic separation, biophysical characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, ChemStation, Empower).Knowledge of industry standards and current FDA and ICH guidelinesHere's What You'll Bring to the Table (Preferred Qualifications)Rich experience with stability and forced degradation studies as well as stability indicating properties and analytical assays for biologics and/or small molecule therapeuticsExcellent written and oral communication skills; strong organizational skills and attention to detail(Preferred) Familiarity with electronic notebooks, LES, LIMS and quality management systemAbility to work independently and as part of a team, self-motivation, adaptable, and a positive attitude.Ability to prioritize work and experience in managing multiple projects in a fast-paced environment.A desire to make an impact as part of a high-growth, transformational company that isBold, Relentless, Curious, and Collaborative.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 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) -
