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This position will be based in our Clinical Manufacturing sites at Burlington. The individual in this role will be part of a cohesive team responsible for supporting Clinical cGMP plasmid produced at Moderna. The successful candidate will have experience in clinical manufacturing as well as lot disposition. Strong decision-making skills and independent thinking will be paramount for candidate success. They will interact fluidly with peers and supervisors in Quality, as well as cross-functionally with Manufacturing and other supporting functions. The shift is 1st shift from 7:00 AM to 5:00M Wednesday through Saturday. Here's What You'll Do: Perform lot disposition of Plasmids. Perform review of executed electronic and paper batch record documentation. Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review. Perform review of environmental monitoring data. 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Currently enrolled in an Bachelor's degree program in a relevant scientific discipline Familiarity with relevant and current FDA, EU and ICH guidelines and regulations is preferred Knowledge of cGMP, good documentation practices and general laboratory safety is preferred General knowledge of quality control laboratory operations is preferred A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255478151", "isPrivate": false}, {"id": 309255781696, "name": "Sr. Specialist, Tech Ops", "location": "Norwood, Massachusetts", "locations": ["Norwood, Massachusetts"], "hot": 0, "department": "Quality", "business_unit": "Jerh Collins", "t_update": 1701573148, "t_create": 1695340800, "ats_job_id": "R14297", "display_job_id": "R14297", "type": "ATS", "id_locale": "R14297-en", "job_description": "The Role: Moderna is seeking an experienced and knowledgeable Sr. Specialist, Quality Assurance to provide technical quality assurance oversight for Individualized Neoantigen Therapy (INT) manufacturing. This position will be based out of our cGMP Manufacturing site in Norwood, MA. This individual's expertise in making complex quality decisions will be essential in supporting deviations, technical reports, characterization studies, technology transfer, and commercial readiness. The individual in this role will be responsible for supporting cGMP mRNA drug substances and products produced internally at Moderna for the INT program. This individual will work closely with technical Subject Matter Experts (SMEs) and be responsible for ensuring compliance with regulatory filing commitments and operational success. A successful candidate will be versatile, resilient, and demonstrate an understanding of phase-appropriate clinical production, ideally with direct experience supporting manufacturing and/or packaging operations within the biopharmaceutical industry. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, MS&T, Logistic, Regulatory, Process Engineering, Validation and Process Development Technology Transfer counterparts to assess and implement new processes and continuous improvement initiatives. This is a Monday - Friday day shift. Here's What You'll Do: Collaborate closely with technical SMEs to understand product specifications, manufacturing processes, and quality standards. Support manufacturing continuous improvement initiatives and technology transfer projects. Provide guidance and support for technical reports and characterization studies, ensuring they meet quality standards and regulatory expectations. Assess commercial readiness of products, ensuring they meet quality, safety, and regulatory requirements before market launch. Identify potential risks, quality issues, and deviations from established standards, and work with cross-functional teams to develop appropriate solutions. Proven ability to make informed processing decisions based on technical expertise and understanding of quality standards. Identify potential risks, quality issues, and deviations from established standards, and work with cross-functional teams to develop appropriate solutions. Responsible for providing quality assessment for change controls related to new product introduction and major process changes. This includes providing plan creation oversight and verifying that changes adhere to SOPs and regulatory compliance. Ability to work independently and manage multiple projects simultaneously. Quality certifications such as ASQ Certified Quality Engineer (CQE) or similar are preferred. Here's What You'll Bring to the Table: Bachelor's degree in Sciences or Engineering discipline with 6+ years OR Master's degree with 2-5+ years' experience, with applied industry experience. Prior experience providing Quality technical support in a cGMP environment, with on-the-floor experience preferred. 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. 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. 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Demonstrated ability to work in a risk-based CSV environment following the associated regulatory expectations. Knowledge of Software Development Life Cycle (SDLC) principals including planning, analysis, design, development, testing, implementation, and maintenance is required. Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired. Experience and proficiency with CSV audit for Research computerized systems is desired. Practical understanding of GAMP and ERES standards and guidance. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations (understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11. Expertise with business office applications, word processing and spreadsheets. 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The candidate must be able to drive results on multiple complex assignments simultaneously, in addition to reviewing and guiding the work and performance of FTEs and contractors. Provide strategic direction and leadership for the CQV Global Org, aligning it with the overall business objectives of the F&E organization. Foster a culture of good engineering practices, quality excellence and continuous improvement within the F&E team and across the organization. Oversee the development and execution of qualification & validation master plans, risk assessments, and validation strategies for manufacturing processes and equipment. Support CQV quality records and ensure appropriate corrective and preventive actions are identified and implemented. Oversee the validation activities related to DS and DP manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements and quality standards. 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