Analyst QC CRS

Location: Malvern

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

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.

They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. The position requires analytical testing to be completed in compliance with all applicable procedures, standards and GMP regulations. This position requires high attention to detail, organizational leadership, interpersonal skills, a quality mindset, and critical thinking, and technical writing skills.

Key Responsibilities:

• Perform analytical testing in compliance with applicable GMP regulations while maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations.
• Maintain individual training completion in a compliant state
• Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical drug substance, drug product, characterization, and/or critical reagent samples
• Review and approve QC data, test records; escalate out-of-specification (OOS) results and support investigations.
• Execute and document sample receipt, chain-of-custody, sample preparation, testing, and data review in accordance with SOPs and GMP.
• Experience with viral vector handling and manufacturing (lentiviral/retroviral) and understanding of biosafety requirements.
• On-site laboratory work in a controlled environment with BSL-2/2+ practices
• Use electronic systems (eLIMS, MES, Empower, etc.) for execution and documentation of testing
• Support of New Product Introductions (NPI)
• Support analytical method qualification, validation, and transfer into the CRS lab, owning change control actions, generation of new documentation, and completing testing activities with mentorship from Sr. Analysts on transfer activities
• Perform Instrument Calibration and/or Preventative Maintenance, as needed
• Order/receive supplies and manage inventory
• Update CRS-owned documents using the Electronic Document Management System (EDMS)
• Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
• Complete invalid assay and support laboratory investigation records
• Complete corrective and preventative actions (ACTs), as assigned
• Assist in the execution of internal audits or…