Manufacturing Associate, CAR T Media Preparation
3 days ago
Summit
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) 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.