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Job Description

The Manufacturing Operations Associate is a critical hands-on position within the Cell Manufacturing team. In this role, you will support the production of clinical cell therapy products. The successful candidate will have extreme attention to detail, dedication to patients, and drive to learn.

This role requires the understanding of and strict adherence to cGMP requirements for cell processing operations involving adherent and suspension cell cultures. The successful candidate will read and interpret Batch Records, SOPs, policies and other relevant work instructions to ensure successful and compliant drug substance manufacturing. In this role, you will also collaborate with Facilities/Operations, Quality, EH&S, Materials Management and related stakeholders to drive efficient manufacturing operations.

Hours for this position are Second Shift (2PM - 10PM). The standard work schedule will be Tuesday – Saturday or Sunday – Thursday (40 hours/week).

Key Duties and Responsibilities

• Learn and perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), interfacing with computerized systems, operating automated process equipment, entering data into log books and batch records, and reporting deviations.

• Learn and demonstrate aseptic technique.

• 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 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.

Knowledge and Skills:

• Ability to follow verbal and written instructions in English

• Basic computer skills including Word, Outlook, and equipment interfaces

• Demonstrated ability to learn new systems and understand new technologies

• Visual acuity and ability to distinguish between the colors red, yellow, blue and green

• Ability to lift up to 50lbs

Education and Experience:

• High school diploma and 2 years of work experience, or the equivalent combination of education and experience in a related field

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