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 (Tuesday - Friday - 3 PM - 1 AM) Purpose and Scope of Position–Contractor/Temp Position Manufacture cell culture media preparation in support of client's CAR T manufacturing per Standard Operating Procedures (SOPs) in a controlled, cleanroom environment. Required Competencies: Knowledge/Skills and Abilities 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 Duties and Responsibilities 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. Education and Experience 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. Working Conditions 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. #J-18808-Ljbffr Spectraforce Technologies