Manufacturing Associate CAR T Media Preparation

Spectraforce Technologies; Summit (NJ); On-site; USD 24,796 - 33,062; Full time

Job summary

Spectraforce Technologies in Summit, NJ seeks a Manufacturing Associate for CAR T media preparation. The role supports CAR T manufacturing in a GMP cleanroom and follows SOPs.

Responsibilities include maintaining up-to-date training records for GMP procedures, coordinating with Warehouse Operations to move materials into process suites, and participating in shift handoffs to ensure seamless operations. A degree in an associated field or several years of manufacturing experience are preferred.

Qualifications

• Understanding media and buffer preparation for cell culture and aseptic techniques.
• Familiarity with cGMP/FDA regulated industry.
• Basic mathematical skills.
• Ability to read, execute and document GMP batch records.
• Proficient in MS Office applications.
• Background in biology, chemistry, or pharmaceutical processing.

Responsibilities

• Maintain up-to-date records for training on GMP procedures for media and buffer preparation.
• Assist with lab support activities and coordinate with Warehouse Operations to move materials.
• Participate in shift exchanges to ensure seamless operations.
• Other duties as assigned.

Skills

Media preparation

Aseptic processing

cGMP/FDA awareness

Basic math

GMP batch records

Biology/chemistry background

Education

Associate/Medical Technical degree

HS diploma/GED with manufacturing experience

Tools

MS Office

Job description

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.