• Job Description

  Req#: R14433

  The Role:

  A Manufacturing Associate II (MA II) within the INT Drug Product Operations group is tasked with the vial filling, visual inspection, labeling, and packaging (Fill Finish) of Moderna's mRNA Drug Products. This role is based at Moderna's GMP Manufacturing facility in Norwood, MA. The position involves working 12-hour shifts in Drug Product Manufacturing, ensuring day-time coverage. Shift is 6:00 AM – 6:00 PM, on a rotating 3 x 2 x 2 x 3 schedule:

  • Friday-Sunday ON

  • Monday-Tuesday OFF

  • Wednesday-Thursday ON

  • Friday-Sunday OFF

  The person in this role will join a unified team tasked with supporting the production of GMP mRNA-based medicines for human clinical trial evaluation, through the execution of vial filling, visual inspection, and labeling and packaging activities. The ideal candidate will proficiently document all activities following cGMP guidelines and have the ability to communicate effectively with colleagues and supervisors in Manufacturing, as well as cross-functional teams in Manufacturing Sciences and Technology, Quality Control, Quality Assurance, Logistics, and Process Development Technology Transfer.

  Here’s What You’ll Do:

  • Regularly perform manual and automated filling, visual inspection, labeling, and packaging using disposable technologies, paper batch records, electronic records, and Manufacturing Execution Systems (MES).

  • Exhibit a general understanding of standard manufacturing practices and equipment.

  • Manage tracking and reordering of all filling, labeling, and packaging materials and consumables.

  • Collaborate with Supply Chain to maintain inventory and review process orders.

  • Work closely with QA and QC peers to execute fill finish activities.

  • Assist in investigating and troubleshooting technical and compliance issues.

  • Escalate any issues to the direct supervisor.

  • Reviewing documentation (electronic and paper documentation).

  • Maintain personal training compliance and support the training of various supporting functional groups.

  • Strictly comply with current good manufacturing practices (cGMP), standard operating procedures (SOPs), and manufacturing documentation.

  • Establish and follow written procedures for clear and precise documentation of equipment operation, process instructions, and process data.

  • Uphold safe work habits and adhere to Moderna's safety procedures and guidelines.

  • Capability to manage projects for continuous improvement.

  • Effectively collaborate in a dynamic, cross-functional matrix environment.

  • Flexibility to work off hours and overtime as necessary to meet clinical demand and process schedules.

  Here’s What You’ll Bring to the Table:

  • A STEM degree with 2-5 years of relevant cGMP experience, or 5-8 years of highly relevant equivalent cGMP drug product experience in the absence of a degree.

  • Proficient in effectively training individuals on procedures and providing on-the-job training.

  • Preferred experience in aseptic techniques within biosafety cabinets, laminar flow hoods, and isolators.

  • Capability to gown into cleanroom environments.

  • Able to work collaboratively with peers and demonstrate effective teamwork.

  • Proficient in computer use for various business aspects, including executing electronic batch records, viewing procedures, and reviewing and approving documents.

  • A proactive and ambitious attitude to take on responsibilities and drive process improvements.

  • Experience in electronic batch records, Syncade, OSI PI, Veeva, and SAP is preferred.

  • Demonstrated success in a fast-paced production environment at a biotech/pharmaceutical company, preferably in GMP or GLP.

  • Familiarity with robotics, automation, and HMI navigation is beneficial.

  • Implement 5S methodology and organize the manufacturing area, office space, and documentation storage zones is a plus.

  • Embodies Moderna’s core values: Bold, Curious, Relentless, 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.
  
  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. (EEO/AAP Employer)

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• About the company

  091 Moderna, Inc., is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.

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