The RoleIn this role, you will be part of a cohesive team responsible for producing high quality mRNA-based medicines for production specializing in Moderna's Individualized Neoantigen Therapy. The Manufacturing Sr. Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support projects as well as day to day operations through deviation and CAPA writing with a focus on but not limited to DNA, mRNA, or Fill Finish Operations. The Sr. Specialist will be a key player during Marlborough operational readiness efforts by supporting startup activities, investigating issues that arise, and driving projects within the team focused on delivering results in an efficient manner. This position will be M-F, with occasional tasks outside of working hours to support 24/7 operations.Here's What You'll DoPractice and promote safe work habits and adheres to safety procedures and guidelinesUtilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected eventsLead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)Conduct document revisions and/or document management including batch production records and manufacturing proceduresParticipate in additional user forums for gathering ongoing requirements and prioritization and triage issuesFollow-up on requests, issues, and projects and report statuses to manager/ working teamsMay perform metric trendingGenerate technical protocols and reportsSupport internal and external auditsWork independently with minimal supervision and directionPerform work that consistently requires independent decision making and the exercise of independent judgment and discretionHere's What You'll Need (BasicQualifications)Bachelor's Degree with 8-10 years of experience in biopharmaceutical operations or a Master's Degree with 5+ years industry experience; Degree in Engineering or Life Sciences is preferredHere's What You'll Bring to the Table (Preferred Qualifications)Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique), drug product operations or a similar complex specialized environmentA comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner TregoeA comprehensive understanding of regulatory requirements and their applications in a cGMP environmentMinimum of 2 years' experience with deviation/investigation management systems or a similar technical writing system in a cGMP environmentExcellent written and oral English language skillsDemonstrated ability to lead cross functional teams and deliver results with minimal supervisionAbility to manage multiple competing priorities in a fast-paced environmentExperience working with electronic batch records and thorough understanding of 21 CFR part 11 requirementsBackground in lean manufacturing methodologies and operational excellenceExperience interacting with representatives of regulatory agenciesProject management experienceA 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) -
