Impactful QC Clinical Release & Stability Analyst

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; Malvern (Chester County); On-site; USD 90,000 - 120,000; Full time

Job summary

Johnson & Johnson in Malvern, PA is seeking a QC CRS Analyst to perform analytical testing of cell and gene therapy related substances and reagents in a cGMP environment. You will collaborate with QA, Manufacturing, and Analytical Development to support releases and method transfers.

The role requires a bachelor’s degree in a relevant science and at least 3 years of laboratory experience with GMP practices, with strong data review, documentation, and problem-solving skills.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, Biotechnology, or related field.
• 3 years of laboratory experience in a pharmaceutical/biotechnology setting.
• Familiarity with GMP and laboratory documentation practices.

Responsibilities

• Perform analytical testing of drug substances, drug product, characterization, stability, and reagents.
• Execute assays such as Flow Cytometry, qPCR/ddPCR, ELISA, cell-based assays, and endotoxin testing.
• Review laboratory data for accuracy and ensure ALCOA+ and GMP compliance.
• Support method transfers, investigations, and CAPAs, and assist with deviations and change controls.
• Maintain training records and stay qualified on analytical methods.

Skills

Analytical reasoning

Quality mindset

GMP knowledge

Documentation proficiency

Education

Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, Biotechnology, or related

Tools

eLIMS

MES

Empower

EDMS

Job description

Johnson & Johnson in Malvern, PA is seeking a QC CRS Analyst to perform analytical testing of cell and gene therapy related substances and reagents in a cGMP environment. You will collaborate with QA, Manufacturing, and Analytical Development to support releases and method transfers.

The role requires a bachelor’s degree in a relevant science and at least 3 years of laboratory experience with GMP practices, with strong data review, documentation, and problem-solving skills.