QC Microbiology Supervisor- CAR-T

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for QC Microbiology Supervisor- CAR-T! This position will be located in Raritan, NJ. The role will fall under the following shift: Wednesday-Saturday 2pm-1am.

Johnson & Johnson Innovative Medicine (JJIM), 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 Quality Control Microbiology department supports manufacturing activities while overseeing the laboratory assays.

Role Objective

The Supervisor, QC Microbiology CAR-T Manufacturing is responsible for technical execution of day-to day activities for the Quality Control Microbiology laboratory, ensuring GMP compliance, accuracy, and timeliness of specified  testing processes. They are responsible for carrying out duties in adherence to all local, state, and federal regulations and guidelines (FDA, EPA, and OSHA) as well as all company and site policies and procedures. In partnership with the QC Supervisors, they also provide QC mentorship and support throughout the JJIM Supply Chain (JSC) for new initiatives, projects, product transfers, and regulatory inspections.

Major Responsibilities

• Create, review and approve relevant QC documents, SOP’s and WI’s.

• Utilize electronic systems (eLIMS) for execution and documentation of testing.

• Manages a team of analysts within the Micro QC department based on assigned work, direction, coaching and developing capabilities.

• Responsible for test method verification, qualification and/or transfer activities in the Micro QC lab.

• Participate in CAR-T manufacturing facility commissioning and qualification.

• Responsible for the approval of environmental monitoring data.

• Provide oversight of gown qualification/requalification of personnel and assist staff in cleanroom as needed.

• Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.

• Initiate and approve quality investigations, CAPAs, and change controls related to microbiology.

• Schedule and review all microbiology testing not limited to: compressed gas sampling, bioburden, Routine Environmental Monitoring, sterility, mycoplasma and endotoxin testing.

• Support Aseptic Process Simulations and visual inspection of components.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Key Competencies/Skills/Requirements

• Aseptic processing in ISO 5 clean room and biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products.
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment for microbiological testing/assays.
• Detailed knowledge of the shop floor manufacturing process.
• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC Microbiology.
• Comprehensive knowledge of tren