QC Release & Stability Analyst - Cell & Gene Therapy

Johnson & Johnson Innovative Medicine; Malvern (Chester County); On-site; USD 90,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking a QC Clinical Release & Stability (CRS) Analyst in Malvern, PA to perform analytical testing of cell and gene therapy products and reagents in a cGMP environment. You will collaborate with QA, Manufacturing, and Analytical Development to ensure timely release of high-quality data.

This role requires 3 years of lab experience, GMP familiarity, and strong data integrity mindset, with opportunities to lead methodological transfers and continuous improvement projects.

Qualifications

• Bachelor's degree in a science discipline required.
• 3 years of pharma/biotech lab experience.
• Familiarity with GMP and lab documentation practices.
• Experience with biological or analytical testing methods.
• Ability to interpret SOPs and test protocols.
• Strong organizational and communication skills.

Responsibilities

• Perform analytical testing of drug substances, product, and reagents.
• Execute assays such as flow cytometry, qPCR/ddPCR, ELISA, endotoxin tests.
• Review data for accuracy; document tests in approved systems.
• Support method transfers, investigations, CAPAs, and improvements.
• Maintain training records and remain qualified on methods.

Skills

Analytical reasoning

Data analysis

Quality control

Lab documentation

Problem solving

Communication

Attention to detail

Compliance

Lean/Six Sigma

Flow Cytometry

Education

Bachelor's degree in Biology/biochemistry/microbiology/chemistry/biotechnology or related

Tools

eLIMS

MES

Empower

EDMS

Job description

Johnson & Johnson is seeking a QC Clinical Release & Stability (CRS) Analyst in Malvern, PA to perform analytical testing of cell and gene therapy products and reagents in a cGMP environment. You will collaborate with QA, Manufacturing, and Analytical Development to ensure timely release of high-quality data.

This role requires 3 years of lab experience, GMP familiarity, and strong data integrity mindset, with opportunities to lead methodological transfers and continuous improvement projects.