Sr. Manufacturing Associate I

The Role:

A Sr. Manufacturing Associate I 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 shift in Fill Finish Drug Product Operations will be days 12 hours 6:00AM-6:00PM 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.

Here’s What You’ll Do:

• Act as on the floor leader for the team in support of the shift supervisor to organize and ensure the quality and timeliness of executing daily activities.

• 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.

Here’s What You’ll Bring to the Table:

• STEM degree with at least 5-7 years’ relevant cGMP experience or 8-10 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.

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 per