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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Job Description:

Johnson & Johnson is currently recruiting for a CAR-T Specialist 3, Quality Assurance Microbiology. This position will be located in Raritan, NJ.

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 https://www.jnj.com/.

[CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

The Microbiology Specialist, Quality Assurance will join the Quality Assurance workstream and be closely connected with Operations and Quality Control workstreams. You will have the opportunity to develop extensive knowledge in the highly innovative Advanced Therapy Medicinal Product manufacturing process and contribute to a significant impact on the health of our patients. This position will based at the CAR-T manufacturing facility in Raritan, NJ.]

Key Responsibilities:

• Serve as an aseptic processing expert for CAR-T and train individuals on aseptic processing.
• Develop, track, maintain, and deliver accurate data, metrics, and reports to support CAR-T manufacturing environment locally and in collaboration with other global ATMP manufacturing sites.
• Explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation.
• Review and approve non-conformance investigations in your area of expertise.
• Identify risks and opportunities in relation to process, contamination, and cross-contamination associated with the manufacturing environment and drive follow up initiatives for improvement in close collaboration with operators, QA, QC and operations management.
• Ensure compliance with all regulatory requirements particularly in the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
• Act as a spokesperson for your area during health care inspections. ]

Qualifications

Education:

A minimum of a Bachelor's degree is required with a focus in Biological Sciences such as Microbiology, Molecular Biology, Biochemistry, or a related field preferred.

Experience and Skills:

Required:

• Minimum 2-4years working experience in a GMP regulated environment.
• Solid understanding of aseptic manufacturing and aseptic controls.
• Excellent written and oral communication skills.

Preferred:

• [Proficiency in analytical skills such as data analysis and data visualization.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
• Empowered professional who drives a Quality Mentality and can make well motivated pragmatic decisions on their own.
• Connect easily at all levels in the organization and lead by example.
• Demonstrate a steadfast work ethic and a passion for overcoming obstacles.

Other:

• This position is anticipated to have up to 10% traveDemonstrate a steadfast work ethic and a passion for overc