Analyst Qc Crs

Johnson & Johnson

Malvern, Pennsylvania, United States of America
Base: $79,000.00 - $127,650.00; bonus/equity: elig...
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Analytical testing
Gmp-compliant documentation
Cell and gene therapy products
** Johnson & Johnson is seeking an experienced QC CRS Analyst in Malvern, Pennsylvania, to conduct analytical testing and ensure compliance with GMP regulations for cell and gene therapy products. The ideal candidate will have substantial experience in laboratory settings, particularly with CAR-T therapies, and possess strong analytical and organizational skills. **

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.
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking an experienced QC CRS Analyst in Malvern, Pennsylvania, to conduct analytical testing and ensure compliance with GMP regulations for cell and gene therapy products. The ideal candidate will have substantial experience in laboratory settings, particularly with CAR-T therapies, and possess strong analytical and organizational skills. **

Salary

Base: $79,000.00 - $127,650.00; Bonus/Equity: Eligible for long-term incentive program; 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

  • analytical testing
  • GMP-compliant documentation
  • cell and gene therapy products
  • CAR-T
  • biochemical and testing
  • method qualification/validation

Nice-to-have

  • organizational leadership
  • quality mindset
  • critical thinking
  • technical writing skills
  • continuous improvement
  • lean practices

Key Requirements

  • Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry or related field
  • 4–6 years of hands-on experience in cell therapy or biologics laboratories
  • Demonstrated experience with flow cytometry, qPCR/ddPCR, and cell-based assays
  • Strong understanding of GMP/GLP principles
  • Experience with QC documentation practices

Work Rights

Not specified

Tailored Resume

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