Job Description

The Manufacturing Operations Senior Associate is responsible for daily GMP manufacturing operations including the assembly, set-up, operation, disassembly, and cleaning of process equipment.

Shift: Sunday-Wednesday 7:00am - 5:30pm est

The ideal candidate will be proactive, have leadership, research or volunteer experience, and a solid background in upstream.

Key Duties and Responsibilities:

• Perform clinical product manufacturing for cell therapy according to cGMP standards - Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations
• Demonstrates and assists others with aseptic technique
• May participate in technology transfer and final process development from the Development to the Manufacturing group - Occasionally supports the development of Standard Operating Procedures (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 - Transfer raw material inside cleanroom suite using sanitizing reagents
• Supports Operations group to ensure proper coordination of resources
• Ensures 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
• Works in a cleanroom and office setting
• 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
• Compressed gasses and LN2 are used in this process

Knowledge and Skills:

• Ability to follow verbal and written instructions in English
• Visual Acuity
• Ability to distinguish between the colors red, yellow, blue and green
• Ability to lift up to 50lbs
• Solid communication and documentation skills
• Organizational skills
• Basic computer skills and demonstrated ability to learn new systems and understand new technologies
• Ability to perform shift work as required.

Education and Experience:

• Bachelor's Degree preferred
• Bachelor's Degree and 3+ years of experience, or the equivalent combination of education and/or several years' experience in a related field

Pay Range

$45-$53/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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No C2C or Third-Party Vendors