Johnson & Johnson Careers
EM Read Specialist, CAR-T Manufacturing
Raritan, New Jersey
Requisition ID: 9696190820
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for an EM Read Specialist, CAR-T Manufacturing.
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 EM Read Specialist, CAR-T Manufacturing will:
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Participate in training and delivery of Operations aseptic technique and microbiology awareness training program.
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Detect, quantify, identify and investigate any contaminants if found during EM monitoring of the manufacturing process and provide guidance on CAPAs
• Perform peer review/approval of laboratory data.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Support media incubation, growth promotions, and plate reading.
• Manage inventory of EM materials
• Ensure all microbiology testing equipment, incubators and facilities are maintained in a compliant manner at all times
• A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required.
• A minimum of two (2) years within a biological and/or pharmaceutical industry is required
• An advanced degree (MSc., Ph.D.) in a related field is preferred.
• Relevant micro experience related to manufacturing is required.
• Experience in a Quality Control setting is preferred
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practices is required.
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred
• Detailed knowledge of the shop floor manufacturing process is preferred
• Comprehensive knowledge of trending using statistical analysis is preferred
• Ability to pay attention to details and follow the procedures is required
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Excellent written and oral communication skill are required
• 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 is located in Raritan, NJ and may require up to 10% of domestic 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)