Johnson & Johnson Careers

QC Supervisor, CAR-T (3rd shift)

Malvern, Pennsylvania
Quality Control


Job Description

Requisition ID: 2414190422


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, CAR-T will:

• Be responsible for the efficient and effective functioning of the Quality Control Car-T lab including the planning, coordination and direct supervision of activities being conducted by Quality Control Scientists.
• Acts as primary contact for manufacturing for testing conducted within the functional laboratory
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Make QC disposition decisions regarding the compliance of batches with established release testing specifications
• Review statistical analysis, data trending, and reporting
• Approve invalid assay and general laboratory investigation records
• Ensure accuracy and completeness of executed analytical method qualification, validation, and transfer activities
• Set testing priorities and manage work assignments
• Generates shift schedules, where required, to ensure efficient coverage for all operational needs
• Maintain individual training completion in a compliant state
• Complete corrective and preventative actions (CAPA) as assigned
• Independently execute and manage change control processes
• Lead internal/external audits
• Lead Quality risk assessment teams
• Support Health Authority inspections
• Review/approve documents as a QC department subject matter expert (SME)
• Ensures laboratory equipment is qualified, maintained and calibrated, as required
• Maintain an orderly laboratory through routine housekeeping
• Provides support for troubleshooting methods and assays
• Review/approve purchase requisitions for laboratory supplies
• Develop business cases for capital projects associated with the QC laboratories
• Support interactions with suppliers/customers
• Coordinate and manage stability studies
• Lead functional laboratory staff meetings
• Participate as a technical resource and departmental representative on multi-functional, interdepartmental teams
• Support continuous improvement teams
• Provide leadership and insight as a member of global project teams
• Lead escalation meetings for QC laboratory quality issues

Qualifications
• A minimum of a Bachelor’s degree is required
• A minimum of six (6) years of professional business related experience. 
• A minimum of four (4) years of experience directly supervising employees 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
• Extensive experience reviewing/auditing laboratory documentation is required
• Ability to quickly process complex information and often make critical decisions with limited information is required
• Proficient in applying process excellence tools and methodologies is preferred
• Ability to independently manage a portfolio of ongoing projects is preferred
• Detailed knowledge of financial concepts and terminology associated with capital project/budget responsibilities of the position is preferred
• Detailed knowledge and experience in applying statistical concepts to laboratory data is preferred
• Detailed knowledge of requirements for managing stability studies is preferred
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required
• This position is on 3rd Shift during the period it is located in Malvern, PA. 
• This position is located in Malvern, PA temporarily and requires up to 10 % travel to regional sites. This position will be located permanently in Raritan, NJ beginning in 2020. 


Primary Location
United States-Pennsylvania-Malvern-
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Control
Requisition ID
2414190422