Manufacturing Specialist (Contract)

Vertex Pharmaceuticals • Boston, MA

11d • $48 - $53 • Onsite

About The Position

This is a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals. The Manufacturing Specialist will 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 demonstrating and assisting others with aseptic technique, potentially participating in technology transfer and final process development, and supporting the development of SOPs or other documentation. The specialist will ensure raw materials are identified and available, transfer raw materials into the cleanroom, and support the Operations group for resource coordination. Maintaining cGMP compliance is crucial. The role requires adherence to 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.

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

• 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
• Demonstrate and 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 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