Sr. Manufacturing Associate I, Label & Packaging

The Role

The Sr. Manufacturing Associate I, Drug Product Label & Packaging is an experienced, hands-on operator and shift resource supporting cGMP labeling and packaging operations for Moderna's parenteral drug product presentations, including vials and prefilled syringes. This role independently executes routine and complex packaging activities, supports and may lead line readiness and changeovers, maintain disciplined label control and reconciliation, and serves as a reliable troubleshooting and escalation resource during daily operations.

This position emphasizes accuracy, right-first-time execution, strong documentation habits (ALCOA+), timely escalation, and collaboration to ensure packaged products meet quality, regulatory, serialization, and market requirements. Success looks like consistent independent execution, effective peer coaching, strong ownership of line performance, and growing leadership across safety, quality, documentation, and throughput.

Here's What You'll Do

Execute packaging operations per approved SOPs and cGMPs, including (as qualified/assigned):

• Lead and/or execute line setup, operation, and changeover activities for labeling and packaging processes (e.g., label application, cartoning, kitting, aggregation/case packing where applicable), ensuring correct configuration and readiness prior to start.
• Perform and verify line clearances, room/equipment readiness checks, and controlled material/component staging to support compliant operations and minimize mix-ups.
• Execute and verify label control activities, including label issuance/use/return, segregation, reconciliation, and disposition support per procedure; ensure counts and documentation are accurate and complete.
• Conduct and document in-process checks and inspection/verification steps (e.g., barcode/label verification, vision checks, print/scan verification where applicable) and take appropriate action within procedures.
• Complete accurate, contemporaneous documentation (ALCOA+), including logbooks, batch record entries, and electronic transactions (MES/eBR/labeling systems as applicable); review own work and support peer review for completeness and accuracy.
• Verify equipment status/readiness, including calibration labels, PM tags, cleaning status, and required pre-use checks; escalate gaps before processing begins.
• Identify, contain, and escalate deviations, atypical events, and equipment/system issues; perform intermediate troubleshooting within training and follow escalation pathways to reduce downtime and maintain compliance.
• Support shift-level investigation activities, CAPAs, and change controls for packaging-related events by providing factual timelines, observations, and clear documentation; may support implementation of corrective actions on the floor.
• Train, coach, and support qualification of associates through structured OJT, peer guidance, and demonstration of proper technique; promote consistent execution, cGMP behaviors, and safe work practices.
• Maintain compliance with gowning requirements (as applicable), controlled-area behaviors, safety protocols, and 5S/housekeeping standards; model safe and compliant behaviors for the team.
• Collaborate effectively with cross-functional partners during routine and non-routine operations (QA/QC, MS&T, Engineering, Supply Chain, Digital/Systems), including support of equipment readiness, engineering runs, and process improvement activities.
• Participate in and support continuous improvement activities related to safety, quality, documentation, throughput, reconciliation, and line performance.
• Flexibility to work off-hours, weekends, overtime, and different shifts as needed to meet production demands and business needs.

Here's What You'll Need (Basic Qualifications)

• High School Diploma / GED required; Associate's or Bachelor's degree in a scientific/technical field preferred (or equivalent experience).
• Typically 3-5 years of experience in GMP manufacturing or regulated operations; labeling/packaging experience in pharma/biotech strongly preferred.
• Demonstrated ability to independently execute routine and complex work while maintaining strong documentation practices (ALCOA+).
• Experience with packaging batch records, line clearance, in-process checks, label control/reconciliation, and basic to intermediate equipment/system troubleshooting preferred.
• Ability to support training, peer coaching, escalation, and shift-level problem solving in a compliant manufacturing environment.
• Comfort working in controlled environments with standing for extended periods, following gowning/PPE requirements, and performing repetitive tasks with high attention to detail.
• Ability to lift up to ~35 lbs (or per site standard) and perform physical tasks consistent with packaging operations.

Here's What You'll Bring to the Table (Preferred Qualifications)

• Working knowledge of cGMP expectations, ALCOA+ principles, packaging batch records, logbooks, and electronic manufacturing/labeling systems.
• Strong attention to detail with disciplined documentation, reconciliation, and line-clearance habits.
• Clear communication skills with the ability to escalate issues promptly and provide accurate handoffs.
• Ability to work effectively in a team environment and serve as a positive peer resource for newer associates.
• Demonstrated ownership mindset, reliability, flexibility, and commitment to safety, quality, and continuous improvement.