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.
