Job Description
The Manufacturing Operations Senior Associate is a critical hands-on role within Cell Manufacturing. This position is responsible for GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have extreme attention to detail, technical writing skills, and commitment to patients.
The work schedule for this position is Wednesday-Saturday, 2nd shift (12:30 pm - 11 pm) for a total of 40 hours/week.
Job Description
The Manufacturing Operations Senior Associate is a critical hands-on role within Cell Manufacturing. This position is responsible for GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have extreme attention to detail, dedication to patients, and drive to learn.
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.
Knowledge and Skills:
• Ability to follow verbal and written instructions
• Minimum 1 year of experience in a GMP environment
• Minimum 6 months experience with cell culture and demonstration of aseptic technique
• Basic computer skills Word, Outlook, and equipment interfaces
Environment:
• 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
Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
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