Johnson & Johnson Careers
QC Supervisor, CAR-T
Raritan, New Jersey
Requisition ID: 9695190820
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Supervisor, CAR-T.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment
The QC Supervisor oversees day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy and timeliness of specified testing processes. The QC Supervisor carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures.
This position is responsible for carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints, resolving conflict and supporting internal and external audits.
The QC Supervisor typically guides daily work activities of 5 – 10 direct reports within a functional laboratory of the Quality Control department
Additional Responsibilities Include:
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Review/approve documents as a QC department subject matter expert (SME)
• Support laboratory investigation of OOS/ invalid assays, CAPAs and change controls
• Ensure accuracy and completeness of executed analytical method qualification, validation, and transfer activities
• Set testing priorities and manage work assignments
• Maintain individual training completion in a compliant state
• A Bachelors degree with a minimum of six (6) years related supervisory experience or a Master Degree with a minimum four (4) years of supervisory experience in a related field or an advanced degree (Ph.D.) with a minimum of two (2) years of supervisory experience in a related field is required.
• Expert knowledge of analytical technologies used in the QC laboratory is required
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems is required
• Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610 is required
• Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is required
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required
• This position will occasionally require to lift up to 20 pounds.
• 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 will be located in Raritan, NJ and may require up to 5% of travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
Janssen Pharmaceuticals, Inc. (6062)