Sr. Manufacturing Associate , 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. A Sr. Manufacturing Associate I, executes, independently and expertly, 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 moderately complex troubleshooting and assists investigations as required.
• As required, perform all end to end clinical & commercial drug substance unit operations.
• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies involving 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.

• Education : HS Diploma
• Experience:
  
  STEM degree with 4 years’ industry experience or an Associates’ degree with 5-8 years’ industry experience or HS Diploma with 8 years’ industry experience
• Specific Certifications or Training:
  None
• Other Quantifiable Preference:
  Strong understanding of GMP regulations.

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you, at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a…