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Scientific. Clinical. Software Engineering

Manufacturing Associate - PM Shift

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -032020-26516 Region: Edison-New Brunswick Metro Area

Job Description

Manufacturing Associate - Several Openings

Day Shift - 4 / 10 hour PM Shift (5p - 5a) including 1 weekend day


JOB DESCRIPTION:


Manufacture of cell culture media and buffers in support of S12 liso-cel CAR T manufacturing per Standard Operating Procedures (SOPs) and cGMP batch records in a controlled, cleanroom environment.


. Required Competencies: Knowledge/ Skills, and Abilities:

- Understanding of media and buffer preparation requirements for cell culture.

- Proficient in aseptic processing and lab techniques.

- Familiarity with cGMP/FDA regulated industry

- Attention to detail will be critical to maintaining quality standards with emphasis on Right the First Time.

- 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


3. Duties and Responsibilities:

- Manufacturing of cell culture media and buffer solutions in a controlled cleanroom environment 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.


4. 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.

Experience working in a Biological Safety Cabinet using aseptic technique.



- Clean room environment is an enclosed, restricted space, with controlled air 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.

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