Senior QC Scientist (CAR-T Manufacturing)

Role:

Location:

Position Type:

Position Summary:

Senior Quality Control Scientist

Key Responsibilities:

• Perform and oversee advanced bioanalytical testing, including

  qPCR, flow cytometry, ELISA, cell count, and cell viability assays

  .
• Manage and execute

  microbiological and environmental monitoring (EM) testing

  , including sterility, endotoxin, mycoplasma, and gram staining.
• Review, analyze, and approve

  QC data

  to ensure accuracy,

  compliance

  , and timely release of results.
• Support and guide junior chemists and scientists in laboratory best practices, method execution, and compliance requirements.
• Lead and contribute to

  OOS/OOE investigations, deviations, and CAPA development

  , ensuring thorough

  root cause analysis and effective corrective actions

  .
• Collaborate with cross-functional teams (

  Manufacturing, QA, Regulatory

  ) to support clinical and commercial

  CAR-T manufacturing

  .
• Ensure adherence to cGMP, data integrity, and quality standards across all QC operations.
• Support validation, qualification, and lifecycle management of analytical methods and QC instrumentation.
• Author, review, and revise SOPs, test methods, protocols, and technical reports.
• Drive continuous improvement initiatives within the QC department to enhance efficiency, reliability, and compliance.

Qualifications:

• Bachelors or Masters degree in

  Chemistry, Biochemistry, Microbiology, or related field

  .
• Minimum

  10 years of progressive experience

  in Quality Control within

  pharmaceutical

  ,

  biotechnology, or cell therapy environments

  .
• Proven expertise in

  bioanalytical methods (qPCR, flow cytometry, ELISA)

  and

  micro/EM testing

  .
• Strong understanding of cGMP, regulatory expectations (FDA/EMA), and quality systems
• Demonstrated ability to lead investigations, train staff, and provide technical oversight.
• Excellent documentation, organizational, and communication skills.