Manufacturing Associate - PM Shift
Edison-New Brunswick Metro Area, NJ
Manufacturing Associate - Several Openings
Day Shift - 4 / 10 hour PM Shift (5p - 5a) including 1 weekend day
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.