Janssen Pharmaceutical, amember of Johnson & Johnson's Family of Companies, is recruiting for a QAAssociate III (QPIP), CAR-T Manufacturing.
At the Janssen Pharmaceutical Companies of Johnson& Johnson, we are working to create a world without disease. Transforminglives by finding new and better ways to prevent, intercept, treat and curedisease inspires us. We bring together the best minds and pursue the mostpromising science. We are Janssen. We collaborate with the world for the healthof everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. JanssenBiotech, Inc. is part of the Janssen Pharmaceutical Companies.
JanssenBiotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson &Johnson, and Legend Biotech USA Inc., have entered into a global, strategiccollaboration to develop, manufacture, and commercialize a chimeric antigenreceptor (CAR) T-cell therapy. This innovative strategic partnership isdesigned to combine the strengths and expertise of two companies toadvance the promise of an immunotherapy CAR T platform and investigationaltreatment
The QA Associate III(QPIP), CAR-T Manufacturing will:
Be responsible for on the floor qualityoversight of the production of autologous CAR-T products for clinical trialsand commercial operation in a controlled cGMP cleanroom environment.
Work with Process Development team andOperations organization to successfully transfer process to cGMP facility tomanufacture products.
Support drafting of standard operatingprocedures and batch records.
Real time review of all documentation andreporting in support of process unit operations.
Ensure non-conformances are investigatedthoroughly and approved in a timely manner and appropriate corrective andpreventive action plans are implemented.
Strive to reduce non-conformances in supportedareas by proactively driving compliance.
Perform tasks in a manner consistent with thesafety policies, quality systems and cGMP requirements.
Other duties will beassigned, as necessary
A minimum of a Bachelors Degree in Engineering, Science or equivalent technical discipline is required
A minimum of four (4) years of experience in Quality Assurance related to manufacturing is required.
Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
Experience working with cell therapy is preferred.
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
Knowledge of Good Tissue Practices is required.
Excellentwritten and oral communication skill are required
Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
This position is located in Raritan, NJ and may require up to 5% of domestic travel.
Johnson & Johnson is anAffirmative Action and Equal Opportunity Employer. All qualified applicantswill receive consideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, age, national origin, orprotected veteran status and will not be discriminated against on the basis ofdisability.
Primary Location United States-New Jersey-Raritan- Organization Janssen Pharmaceuticals, Inc (6062) Job Function Quality Assurance Requisition ID 893#######