About The Position

The Quality Control Analyst I - Cell Therapy (AM Shift) is responsible for performing Quality Control assays in support of the release and stability testing of cell therapy products. This position supports clinical and commercial manufacturing programs by executing biological and cell-based assays, maintaining accurate laboratory documentation, and ensuring compliance with cGMP regulations and quality standards. The role offers exposure to a diverse range of analytical techniques within a dynamic Cell Therapy Quality Control environment.

Requirements

  • Bachelor's degree in Life Sciences or a related scientific discipline required.
  • Ability to follow procedures, operate laboratory instrumentation, and maintain accurate records.
  • Strong attention to detail, organizational skills, and commitment to quality.
  • Positive attitude, willingness to learn, and ability to work effectively in a team environment.

Nice To Haves

  • Experience working in a scientific laboratory environment preferred.
  • Exposure to cGMP environments and regulated laboratory practices is a plus.
  • Hands-on experience with Flow Cytometry, qPCR, Cell Counting, ELISA, or related analytical techniques is highly desirable.
  • Demonstrated knowledge of biological and cell-based assays, including flow cytometry, preferred.
  • Understanding of laboratory equipment, aseptic techniques, and sample handling practices preferred.

Responsibilities

  • Perform Quality Control (QC) biological and cell-based testing of Cell Therapy release and stability samples.
  • Execute testing activities in accordance with cGMP requirements and approved laboratory procedures.
  • Maintain complete, accurate, and compliant laboratory documentation, including recording test results and maintaining raw data.
  • Support Cell Therapy technology transfer activities and analytical method validation projects.
  • Participate in training activities related to new methodologies, instrumentation, and procedures.
  • Assist with the generation and maintenance of standard operating procedures (SOPs) and validation documentation.
  • Perform routine laboratory and equipment maintenance activities to ensure operational readiness.
  • Collaborate with Quality Assurance, Operations, and Supply Chain teams to support manufacturing and product release activities.
  • Support investigations, deviations, and other quality documentation as required.
  • Perform additional duties as assigned in support of Cell Therapy Quality Control operations.

Benefits

  • Performance-related bonus.
  • Medical, dental and vision insurance.
  • 401(k) matching plan.
  • Life insurance, as well as short-term and long-term disability insurance.
  • Employee assistance programs.
  • Paid time off (PTO).
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