ÊR T Associate Tech Specialist (1 of 8)

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Tech Specialist, 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. Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! The CAR -T Associate Tech Specialist will be the primary investigator who will provide technical expertise to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support for the investigation and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures sought at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained. Key Responsibilities: Establish corrective actions adequately addressed root cause of NC event. Track deviations, events and key process parameters and provides reports to management on trending, and status as requested. Identify and implement process improvements related to safety, environmental, quality, compliance, efficiency, yield, and cost. Implement process improvements within the change control system. Recognize and act on potential compliance issues and opportunities for process changes/improvement. Partner with all Cells and COE's to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes. Assist with equipment startup and technical training as required. Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements. Serves as Subject Matter Authority (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA). Maintains various databases of production information. Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR). Review and approve SOP and Batch record revisions. Qualifications Education: Minimum of a Bachelor’s or equivalent degree in a Scientific or related field is required Skills and Experience: Required: Minimum 2 years of relevant work experience Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP Excellent written and oral communication skills Preferred: Ability to respond to critical inquiries or complaints from top managers, regulatory agencies, or members of the business community Experience with internal and external regulatory audits Ability to apply various standard programs for data entry and word processing Other: Requires up to 10% domestic travel At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.] 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. Primary Location United States-New Jersey-Raritan-1000 US HIghway 202 Organization Janssen Pharmaceuticals, Inc. (6062) Job Function Operations Requisition ID 2206008799W