Manufacturing Specialist (Contract)

Atrium Works • Boston, MA

10d • Hybrid

About The Position

This is a contract role for a Manufacturing Specialist. The specialist will serve as the floor Subject Matter Expert (SME), authoring and reviewing batch records and procedures, driving right first time execution, and supporting technical projects and tech transfer. The role involves performing clinical product manufacturing for cell therapy according to cGMP standards, including assembling raw materials, following SOPs, aseptic technique, completing batch records, and reporting deviations. The position also involves ensuring raw materials are identified and available, transferring raw materials into cleanroom suites, and supporting the Operations group for resource coordination. 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 as assigned.

Requirements

• 5 to 6 years of cGMP cell therapy manufacturing experience
• Prior document writing experience
• 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

Nice To Haves

• Leadership Experience is a big plus

Responsibilities

• Serve as the floor SME
• Author and review batch records and procedures
• Drive right first time execution
• Support technical projects and tech transfer
• 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
• 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 Vertex Phenotype behaviors
• Complete an accelerated onboarding

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