Manufacturing Associate, CAR T Media Preparation

Job Title: Manufacturing Associate, CAR T Media Preparation
Job Location: Summit, NJ 07901
Duration: 6 Months..

shift available: Q1 Media Prep breyanzi (5AM-530PM sun-tues/ alternating wednesday).

Training schedule:

• The training period may range from 1 to 6 weeks, depending on business needs, as determined by the client.
• The selected candidate is required to maintain full availability, with no planned leave during the entire training period.
• Training will commence with a Monday to Friday, 9:00 AM - 5:00 PM schedule for the initial 1-2 weeks (subject to change based on business needs).
• Subsequently, the schedule will transition to the assigned Quad shift.

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..
(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)

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:
Bachelor's degree
or Associate/ Medical Technical degree and 3 years of Manufacturing or Operations experience
or High School diploma/GED and 2 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.