Title: Manufacturing Associate II – INT Drug Product, Nights
Location: Norwood, MA
Reports to: Supervisor, INT Drug Product Manufacturing
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 night-time coverage. Shift is 6:00 PM – 6:00 AM, 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.
