The Role:This position supports the technical transfer of a novel cancer therapeutic drug, Individualized Neoantigen Therapy (INT), from technical development into Moderna's cGMP manufacturing site in Marlborough. Reporting to the Director of MST, the Sr. Engineer I will be responsible for performing and managing technology transfers of new processes, materials, consumables, buffers, equipment in support of manufacturing.Here's What You'll Do:Lead cross functional Technology Transfer teams and Investigation teams. Track and coordinate project milestones to enable cGMP compliant implementation.Work with Manufacturing, Facilities, Digital, and Quality to implement additional production trains.Partner with Technical Development, Manufacturing, Digital and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.Be the subject matter expert for drug substance, and lipid nanoparticle processes. This includes supporting equipment commissioning/validation, process transfer, MES implementation, troubleshooting, and leading technical investigations.Author process descriptions, technology transfer documents, deviation/investigation reports, technical reports, and manage technical CAPA/change controls.Review process performance trending / metrics using digital information and statistical analysis tools and improve the process based on that analysis.Here's What You'll Bring to the Table:Biochemical engineer, Chemical engineer, or Biochemistry background. Ph.D. with 0-2 years experience or MS with 6+ years experience or BS with 8+ years of experience in a pharmaceutical or biotechnology company. Advanced degree preferred (MS, Ph.D.)Prior leadership experience managing MST, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company. Demonstrated ability to mentor and develop a technical staff.Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.Preferred: Knowledge of digital cGMP tools. For example: SAP, OSI PI, MES (eBR), Unicorn, eQMSModerna 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) -
