Manufacturing Associate CAR T Media Preparation

Job Title:
Manufacturing Associate, CAR T Media Preparation

Job Location: Summit, NJ 07901

Duration: 6 Months

Shift available:

• Media Prep - Shift 2 (Monday - Friday - 3 PM - 1:30 AM)

Manufacture cell culture media preparation in support of client's CAR T manufacturing per Standard Operating Procedures (SOPs) in a controlled, cleanroom environment.

• Understanding of media and buffer preparation requirements for cell culture, and aseptic processing or lab techniques
• Familiarity with cGMP/FDA regulated industry
• Basic mathematical skills
• Ability to read, execute and document steps in a GMP batch record
• Proficient in MS Office applications
• Background to include a basic understanding of biology, chemistry, or pharmaceutical processing

• Maintain up to date records for training on controlled, approved GMP procedures for Media and Buffer preparation to support CAR T manufacturing.
• Assist with Lab Support activities:
  Coordinate with Warehouse Operations to move materials into the process suites and serve as a runner when needed.
• Participate in shift exchanges of information to ensure seamless operations
• Other duties may be assigned, as necessary.

Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience OR High School diploma/GED and 3 years of Manufacturing or Operations experience

This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken

• Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Ability to lift up to 25 pounds.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
• Use of reagents, chemicals, and exposure to sanitization agents are expected.
• Ability to work in the vicinity of strong magnets.
• Potential routine exposure to human blood components is possible.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.