Manufacturing Associate II, Drug Substance Operations

The Role

MTC-S Drug Substance Operations is responsible for the execution of processing and combining mRNA and LMX/LNP for clinical pipeline products as well as commercial seasonal vaccines in a GMP regulated environment. The Individual executes, independently and proficiently, all applicable manufacturing unit operations, as directed, following relevant standard operating procedures and cGMP regulations. The work is conducted within a clean-room environment and typically involves limited physical activity, lifting and standing for periods of time.

• Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely. Utilizing reader-doer for all steps outlined in standard operating procedures, work instructions, and batch execution documentation. Readers are responsible for SOP and batch record compliance, verifying the actions of the Doer, and are accountable for the outcome of the tasks. Doers are responsible for task execution, are expected to understand the task's purpose and are expected to be able to anticipate system response once actions are performed.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.
• Adhere to documented waste handling procedures and respect environmental regulations.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
• As a Qualified Trainer, perform On the Job Training (OJTs) to accelerate the assimilation and training of colleagues on unit operations and supporting business processes.
• Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.
• Perform specific unit operations in which they are fully trained.
• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies including chromatography, multiple filtration methods and nano-mixing operations.
• Filling and dispensing activities to final container closure for finished clinical and commercial drug substance prior to forward processing.
• Able to approve document revisions as delegated by their manager.
• Shift Requirement: 12-hour day shift (6:00 AM–6:00 PM), scheduled Thursday through Saturday, with every other Wednesday required as part of the rotating schedule.

• Education:
  
  HS Diploma
• Experience:
  
  STEM degree with 2-3 years’ industry experience or an Associates’ degree with 3-5 years’ industry experience or HS Diploma with 5 years’ industry experience
• Specific Certifications or Training:
  None

• Working understanding of GMP regulations.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
• At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

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