The Role:Moderna is seeking an Engineer I to join the Process Development team to support development, scale up, transfer and commercialization of drug substances based on mRNA and lipid nanoparticle delivery technologies.Moderna is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The candidate will be focused on unit operations that are standard across the industry such as enzymatic reactions, normal and tangential flow filtration and chromatographic purification. The candidate will support commercial manufacturing processes and execute experiments to support deviation investigations and definition of appropriate process controls to increase process robustness.Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. The successful candidate will possess strong skills in designing and executing high quality bioprocess experiments using quality by design (QbD) and Design of Experiment (DoE) methods, and will collaborate through cross-functional matrix teams. The person in this role will have the opportunity to develop on-line analytics, process modelling and process investigation support. Results will be presented to broader groups allowing great exposure to CMC Strategy, Regulatory, MS&T, and Quality. Prior experience of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, support technology transfer and provide Person-in-Plant (PiP) support for commercial batches. The position will be based out of Moderna's Norwood facility.Here's What You'll Do:Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modelingDefine the process, the critical parameters, and the design spaceCreate high throughput and automated experimental setupsLead experiments to confirm robust process performance across the control spaceCharacterize mRNA properties through collaboration with the analytical teamPrepare process descriptions, technical reports, and communicate findings internally and externally as appropriateCollect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.Here's What You'll Bring to the Table:BS/MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related fieldHands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operationsWorking knowledge of statistical design of experiments (DoE) and analysis of multivariate dataExperience with analytics and biophysical characterization of nanoparticles is a plusKnowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercializationDemonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes is a plusKnowledge of nucleic acid chemistry, lipid chemistry, and biology is a plusAbility to thrive in a diverse and fast paced environmentExcellent written and verbal 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) -
