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:
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. 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $25.00/hr - $26.00/hr.