Johnson & Johnson Careers

Senior Analyst QC CAR-T (1 of 4)

Malvern, Pennsylvania
Quality Control


Job Description

Requisition ID: 0324180508

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Analyst QC CAR-T, located in Malvern, PA.


At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.


Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.


We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.


We are seeking to hire a highly energetic and collaborative Senior Analyst QC CAR-T, with demonstrated expertise in cell and gene therapy to join analytical team, supporting clinical QC release testing for CAR-T products.


The Senior Analyst QC CAR-T conducts biochemical, microbiological and/or general chemical testing of raw materials, in-process, or final product samples submitted to the QC laboratory. This position requires testing to be completed in compliance with all applicable procedures, standards and GMP regulations.


Responsibilities will include but are not limited to:
  • Perform clinical release testing, following appropriate SOPs and work procedures
  • Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner
  • Accurately capturing data in a timely manner, ensuring data integrity and protocol compliance
  • Perform instrument calibrations and/or preventative maintenance
  • Update QC documents using the Document Management System
  • Utilize electronic systems (LIMS, MES, LES, Empower, etc.)
  • Execute analytical method qualification, validation and transfer with guidance
  • Assist in the execution of internal audits
  • Execute change control processes with guidance from supervisor/management
  • Complete corrective and preventative actions (CAPA) as assigned
  • Complete invalid assay and general laboratory investigation records
  • Maintain individual training completion in a compliant state
  • Provide input and take actions as a QC representative at cross-functional meetings


Qualifications
  • A minimum of a Bachelor's degree in biology, immunology or relevant scientific field is required. Master's degree is preferred
  • A minimum of at least 4 years of relevant QC experience is required
  • Experience working in a cGMP environment is required
  • Hands-on experience with CAR-T or other cell and gene therapy products is preferred
  • Expertise in basic immunology techniques mammalian cell culture, multi-color flow cytometry and/or ELISA is required
  • PCR, cytokine and chemokine detection is preferred
  • Working knowledge of LIMS and/or other QC data systems, as well as appropriate GMP quality systems (e.g. SOPs, etc.) is required
  • Experience with the clinical development of cell and/or gene therapy products is preferred
  • Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
  • This position will require occasional travel to Raritan, NJ or Spring House, PA as business demands
  • Candidates must be able to accommodate working outside normal business hours (including nights and weekends) on little to no prior notice

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.


Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United States-Pennsylvania-Malvern
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Control
Requisition ID
0324180508