Jobs at Moderna

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. A Manufacturing Associate I executes, under close supervision, 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.

This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to site-based operations.

• 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.
• Work in grade C environments and ensure 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.
• Once trained, utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
• Understand physical and digital systems governing equipment and processes to enable basic troubleshooting.
• Perform specific unit operations in which fully trained.
• Aseptic processing of mRNA and LMX/LNP to formulate clinical and 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.
• No delegation or approval responsibilities associated with this role.

• Education: HS Diploma
• Experience: STEM degree with 0-1 years' industry experience or an Associates' degree with 2-3 years' industry experience or HS Diploma with 3-5 years' industry experience
• Specific Certifications or Training: None
• Other Quantifiable Preference: Demonstrated ability to learn to gain a strong understanding of GMP regulations.