Manufacturing Associate (Contract)

Atrium Works • Boston, MA

2d • Onsite

About The Position

Perform clinical product manufacturing for cell therapy according to cGMP standards. This includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations. The role may also participate in technology transfer and final process development from the Development to the Manufacturing group, and occasionally support the development of SOPs or other documentation for manufacturing in collaboration with Development and Quality groups. The associate will ensure raw materials are identified and available in time for manufacturing activities, including transferring raw materials inside cleanroom suites using sanitizing reagents. They will support the Operations group to ensure proper coordination of resources and ensure cGMP compliance through consistent execution. The role requires demonstrating Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking. Other duties and projects may be assigned to meet departmental requirements.

Requirements

• 2-4 years manufacturing experience required
• Must be able to remain in a stationary position 50% during processing activities
• Frequently move about inside the cleanroom to accomplish process tasks
• Occasionally moves lab equipment and materials weighing up to 50 pounds

Responsibilities

• Perform clinical product manufacturing for cell therapy according to cGMP standards
• Assemble raw materials
• Follow specific standard operating procedures (SOP)
• Utilize aseptic technique
• Complete batch records
• Report deviations
• Demonstrate and assist others with aseptic technique
• Participate in technology transfer and final process development from the Development to the Manufacturing group
• Support the development of Standard Operating Procedures (SOPs) or other documentation for manufacturing in collaboration with Development and Quality groups
• Ensure raw materials are identified and available in time for manufacturing activities
• Transfer raw material inside cleanroom suite using sanitizing reagents
• Support Operations group to ensure proper coordination of resources
• Ensure cGMP compliance through consistent execution
• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking
• Other duties and projects as assigned to meet departmental requirements

Benefits

• Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• Eligible for overtime pay, in accordance with federal and state requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed