Senior Manufacturing Associate (Contract)

Atrium Works • Boston, MA

1d • 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 (SOPs), aseptic technique, completing batch records, and reporting deviations. The role also involves participating in technology transfer and final process development from the Development to the Manufacturing group, and occasionally supporting the development of SOPs or other documentation for manufacturing in collaboration with Development and Quality groups. Ensures raw materials are identified and available in time for manufacturing activities and supports the Operations group to ensure proper coordination of resources. Maintains cGMP compliance through consistent execution and demonstrates 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.

Requirements

• 3+ years of experience with aseptic technique
• 3+ years of experience working in a clean room

Responsibilities

• Perform clinical product manufacturing for cell therapy according to cGMP standards
• Assemble raw materials
• Follow specific standard operating procedures (SOPs)
• Utilize aseptic technique
• Complete batch records
• Report deviations
• Assist others with aseptic technique
• Participate in technology transfer and final process development
• Support the development of Standard Operating Procedures (SOPs) or other documentation for manufacturing
• 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
• Perform 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: Senior
• Education Level: No Education Listed