Job Title: Manufacturing Associate
Location: Summit, NJ 07901
Duration: 6+ Months
Purpose and Scope of Position-Contractor/Temp Position:
Manufacture cell culture media preparation in support of S12 ide cel CAR T manufacturing per Standard Operating Procedures (SOPs) in a controlled, cleanroom environment. This position is for the Weekday Shift Monday through Friday with shift coverage from 8 am to 4:30 pm. Start and end times are subject to change based on business demands.
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
● High School diploma/GED and 3 years of Manufacturing or Operations experience.
● 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.