Sr. Engineer II, MST, Individualized Neoantigen Therapy

The Role: The Manufacturing Sciences & Technology (MST) team is responsible for ensuring the robust technology transfer and technical support of our mRNA platform in commercial drug substance and commercial drug product cGMP Manufacturing. A Sr. Engineer II, MST, independently and with mastery, will partner with Process Development, Manufacturing Operations, Regulatory, and Quality, to ensure all aspects of technology transfer and technical support are successfully executed and will provide engineering support for process equipment used at the Moderna’s Marlborough cGMP manufacturing facility. Here’s What You’ll Do Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements. Practice and promote safe work habits and adheres to safety procedures and guidelines. Execute tasks precisely as defined in internal guiding documents including, but not limited to standard operating procedures (SOPs) and work instructions. Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections. Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable. Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS. Support technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance. Be the subject matter expert for drug substance and/or drug product processes. Independently, provide complex technical support of cGMP manufacturing including authoring of highly complex technology transfer documents, change control, manufacturing investigations and helping validation activities. Establish and maintain process performance trending / metrics using digital information and statistical analysis tools. Review performance signals holistically and to inform and drive process improvements at the platform level. Collaborate with process development on studies to determine root cause for basic deviations. Lead a cross functional team for highly complex and less defined troubleshooting. Acts as an advisor / mentor for colleagues with less experience on broad-ranging projects with manageable risks and resource requirements. Proactively drive operational improvement projects with limited guidance to align with and deliver the manufacturing equipment and process strategy. Lead design and engineering of highly complex disposable systems used in bioprocessing including aseptic bioprocessing bags and tubing manifolds. Execute highly complex studies to demonstrate equipment fit and process performance. Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing. Author highly complex technical reports and manage highly complex technical CAPA/change controls. MST will provide weekend coverage for Manufacturing Operations this role will require flexibility to work a weekend day on a rotational basis and/or on call. Approval authority for forward processing and author impact assessments for deviations for further Quality review. Able to attend MRB (Material Review Board) if delegated by Director, MST. No delegation authority associated with this role. Here’s What You’ll Need (Basic Qualifications) Education: A bachelor's and/or master’s degree with a focus in biochemical engineering, chemical engineering, biochemistry, or related area of study. Experience: 10+ years industry experience or 8-10 years industry experience with a master’s degree. Other Quantifiable Preference: Comprehensive understanding of GMP regulations, commercial manufacturing, and/or process development. Demonstrated expertise in bioprocessing including fermentation and purification of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, fermentation, enzymatic reactions, formulation, and drug product manufacturing. The capability to manage diverse technical areas. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Here’s What You’ll Bring to the Table (Preferred Qualifications) Experience in biologics process development and scale up / scale down. Experience with single use bioprocessing technologies. Proven track record leading and managing cross functional teams. Knowledge of digital cGMP tools. For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMS. A desire to make an impact as part of a high-growth, transformational company that is Bold, 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 options. Flexible Spending Accounts for medical expenses and dependent care expenses. Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities. Family care benefits, including subsidized back-up care options and on-demand tutoring. Free premium access to fitness, nutrition, and mindfulness classes. Exclusive preferred pricing on Peloton fitness equipment. Adoption and family-planning benefits. Dedicated care coordination support for our LGBTQ+ community. Generous 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 thereafter. Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents. 401k match and Financial Planning tools. Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options. Complimentary concierge service including home services research, travel booking, and entertainment requests. Free parking or subsidized commuter passes. Location-specific perks and extras About Moderna Since 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 people are 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 leavesandaccommodations@modernatx.com . (EEO/AAP Employer) #J-18808-Ljbffr