Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
CAR-T QC Release Testing, Senior Associate Scientist (1 of 5)
Requisition ID: 5149180306
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Associate Scientist, 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
We are seeking to hire a highly energetic and collaborative senior associate scientist, with demonstrated expertise in cell and gene therapy to join analytical team, supporting clinical QC release testing for CAR-T products. The QC Senior Associate Scientist 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. The individual will be responsible for:
- 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 Analytical QC representative at cross-functional meetings
- Bachelor's degree in biology, immunology or other relevant scientific field, with at least 6 years of relevant QC experience OR a Master's degree with at least 2 with relevant QC experience 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 LabWare LIMS and/or other QC data systems, as well as appropriate GMP quality systems (e.g. eSOPs, etc.) is required
Experience with the clinical development of cell and/or gene therapy products is preferred
Experience working in a cGMP environment is required
Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
Janssen Research & Development, LLC. (6084)