A Manufacturing Associate II in the PCV Drug Product Operations group is responsible for vial filling, visual inspection, label and packaging (Fill Finish) of Moderna's mRNA Drug Products. This position is located at Moderna's GMP Manufacturing site in Norwood, MA. The shifts in Fill Finish Drug Product Operations will be 12 hours shifts providing coverage for either days or overnights.
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.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- 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 Moderna's 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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- STEM degree with at least 2-5 years' relevant cGMP experience or 5-8 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 Moderna's core values: Bold - Curios - Relentless - Collaborative.
- 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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About Moderna
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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.