A Manufacturing Associate I in the PCV Drug Product Operations group is responsible for vial filling, visual inspection, label and packaging (Fill Finish) of Modernas mRNA Drug Products. This position is located at Modernas GMP Manufacturing site in Norwood, MA. The shift in Fill Finish Drug Product Operations will be nights 12 hours 6:00PM-6:00AM on a 3 on/2 off/2 on/3 off/2 on/2 off schedule.
The individual in this role will be part of a cohesive team responsible for supporting GMP mRNA-based medicines for evaluation in human clinical trials through execution of vial filling, visual inspection, and labeling and packaging activities. The successful candidate will be able to document all activities performed following cGMP guidelines and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Manufacturing Sciences and Technology, Quality Control, Quality Assurance, Logistics and Process Development Technology Transfer counterparts.
Heres What Youll Do:
Routinely execute manual and automated filling, visual inspection, labeling and packaging/shipping using disposable technologies, manual filling, automation, paper batch records, and Manufacturing Execution Systems (MES).
Demonstrate general knowledge of standard manufacturing practices and equipment.
Tracking and reorder of all filling, labeling, and packaging materials.
Collaborate with Supply Chain, and maintain inventory and review process orders.
Closely partner with QA and QC peers for execution of fill finish activities.
Support the investigation and troubleshooting of technical and compliance issues.
Maintain individual training compliance as well as support training of various supporting functional groups.
Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Practice safe work habits and adhere to Modernas safety procedures and guidelines.
Ability to manage multiple projects in a fast-paced environment and drive for continuous improvement.
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
Flexibility to work off hours and overtime if needed to meet clinic demand and process schedules.
Heres What Youll Bring to the Table:
STEM degree with at least 0-2 years relevant cGMP experience or 2-3 years highly relevant equivalent cGMP drug product experience without a degree.
Aseptic Processing experience required.
Ambitious and self-starting attitude to take on responsibilities and own process improvements.
Experience in electronic batch records, Syncade, OSI PI, eDMS, and SAP preferred.
Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP.
Express Modernas core values: Bold Curious Relentless 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!
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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. Were 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 firstname.lastname@example.org. (EEO/AAP Employer)