Analyst Qc Crs

Johnson & Johnson Innovative Medicine

Malvern, Pennsylvania, United States of America
Base: $79,000.00 - $127,650.00; bonus/equity: not ...
Onsite
Perform analytical testing gmp
Conduct biological testing
Experience with viral vector handling
Johnson & Johnson Innovative Medicine is seeking an experienced QC CRS Analyst in Malvern, Pennsylvania, to conduct biochemical testing and ensure compliance with GMP regulations for cell and gene therapy products. The ideal candidate will possess a background in biology or biochemistry with hands-on experience in analytical testing and a strong understanding of quality control processes

Job Summary

  • The QC CRS Experienced Analyst is responsible for conducting biochemical and testing of drug substance, final product release and characterization samples, and critical reagent qualifications of cell and gene therapy products, including CAR-T.
  • This role is responsible for performing and overseeing analytical release, maintaining GMP-compliant documentation, supporting method qualification/validation, and partnering with manufacturing, QA, and regulatory teams to ensure the safety, identity, purity, potency, and stability of clinical cell therapy materials.
  • The anticipated base pay range for this position is : $79,000.00 - $127,650.00

Matching Summary

Match Score: 85

Johnson & Johnson Innovative Medicine is seeking an experienced QC CRS Analyst in Malvern, Pennsylvania, to conduct biochemical testing and ensure compliance with GMP regulations for cell and gene therapy products. The ideal candidate will possess a background in biology or biochemistry with hands-on experience in analytical testing and a strong understanding of quality control processes.

Salary

Base: $79,000.00 - $127,650.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Perform analytical testing GMP
  • Conduct biological testing
  • Experience with viral vector handling
  • GMP-compliant documentation
  • Support method qualification/validation

Nice-to-have

  • Organizational leadership
  • Quality mindset
  • Critical thinking
  • Technical writing skills
  • Continuous improvement practices

Key Requirements

  • Bachelor's or equivalent degree
  • 4-6 years of hands-on experience
  • CAR-T or T-cell processing experience
  • Experience with flow cytometry, qPCR/ddPCR, cell-based assays
  • Working knowledge of microbiological assays
  • Strong understanding of GMP/GLP principles
  • Experience with QC documentation practices
  • Familiarity with LIMS, ELN

Work Rights

Not specified

Tailored Resume

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