GXP Specialist - Applied Gene & Cell Therapy Center

Primary Location Location S Department Applied Gene and Cell Therapy Center Shift Day (United States of America) Schedule Full time Weekly Hours 40 FTE 1 Employee Status Regular Manufacturing- manufacturing/processing activities, process development, technology transfer, scale up, quality control, and high complexity analysis as directed following established SOPs and protocols. Complete accurate and detailed records and all documentation as required for compliance to GxP. Complete and maintain training required to perform assigned tasks. Participate in the development of new assays and testing of new protocols. Modify and adapt new procedures as requested. Analyze data, perform statistical and graphical analysis of data, and interpret results. Provide qualification and validation support for manufacturing processes, equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP production and analysis of biomedical products or CAP/CLIA requirements for high complexity analysis. Maintain an active role in the laboratory's meetings, presentations, and publications. Present information on research and laboratory work to others at laboratory meetings, journal clubs, and seminars. Operations- Perform day-to-day Translational Core Laboratory operations including cleanroom facilities maintenance and equipment maintenance plus fee-for-service support as assigned. Operate standard laboratory equipment according to protocol. Maintain and repair equipment; monitor proper use by personnel. Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report facility and equipment failure and alarms to laboratory management or QA team. Wear issued pager, or other communication devices, and respond to all emergency calls promptly for critical equipment failure. Compliance- Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Provide Material Safety Data Sheet (MSDS) training according to regulations. Communicate with external vendors to obtain technical information as needed. Assists in daily operations of the laboratory including answering phone, maintaining lab supplies, organization, and cleanliness. Provide written and oral reports to management on a regular basis. Provide appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.). Perform other duties as assigned. Process Improvement- Create, modify and follow Standard Operating Procedures (SOP) and Protocols. Cooperate with performance improvement initiatives and other compliance activities. Interact with QA to coordinate manufacturing, processing and testing activities (i.e. production suite cleaning schedule, release of the production suite, issuance of batch record, etc.). Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks. Maintain required proficiency and competency requirements. Training & Development- Train laboratory personnel on proper laboratory and compliance techniques. Act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management. Job Responsibilities Manufacturing- manufacturing/processing activities, process development, technology transfer, scale up, quality control, and high complexity analysis as directed following established SOPs and protocols. Complete accurate and detailed records and all documentation as required for compliance to GxP. Complete and maintain training required to perform assigned tasks. Participate in the development of new assays and testing of new protocols. Modify and adapt new procedures as requested. Analyze data, perform statistical and graphical analysis of data, and interpret results. Provide qualification and validation support for manufacturing processes, equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP production and analysis of biomedical products or CAP/CLIA requirements for high complexity analysis. Maintain an active role in the laboratory's meetings, presentations, and publications. Present information on research and laboratory work to others at laboratory meetings, journal clubs, and seminars. Operations- Perform day-to-day Translational Core Laboratory operations including cleanroom facilities maintenance and equipment maintenance plus fee-for-service support as assigned. Operate standard laboratory equipment according to protocol. Maintain and repair equipment; monitor proper use by personnel. Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report facility and equipment failure and alarms to laboratory management or QA team. Wear issued pager, or other communication devices, and respond to all emergency calls promptly for critical equipment failure. Compliance- Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Provide Material Safety Data Sheet (MSDS) training according to regulations. Communicate with external vendors to obtain technical information as needed. Assists in daily operations of the laboratory including answering phone, maintaining lab supplies, organization, and cleanliness. Provide written and oral reports to management on a regular basis. Provide appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.). Perform other duties as assigned. Process Improvement- Create, modify and follow Standard Operating Procedures (SOP) and Protocols. Cooperate with performance improvement initiatives and other compliance activities. Interact with QA to coordinate manufacturing, processing and testing activities (i.e. production suite cleaning schedule, release of the production suite, issuance of batch record, etc.). Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks. Maintain required proficiency and competency requirements. Training & Development- Train laboratory personnel on proper laboratory and compliance techniques. Act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management. Development, technology transfer, scale up, manufacturing/processing/ and or testing; Qualifications and validations. Analyze data and assist others. Job Qualifications Required for Technician I-GxP: High school diploma or equivalent 3 - 5 years of work experience in a related job discipline or equivalent combination of education and experience Required for Technician II-GxP: Bachelor's degree in a related field 0 - 2 years of work experience in a related job discipline Required for Specialist GxP: Bachelor's degree in a related field 2 - 5 years of work experience in a related job discipline Expected Starting Range 22.79/hr - 28.53/hr (Tech I) 55,182.40 - 69076.80 (Tech II) 63,086.40 - 80,558.40 (Specialist) About Us At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's. Cincinnati Children's Is Recognized by U.S. News & World Report as atop 10 best Children's Hospitals in the nation for more than 15 years Consistently among the top 3 Children's Hospitals for National Institutes of Health (NIH)Funding Recognized as one of America's Best Large Employers (2025), America's Best Employers for New Grads (2025) One of the nation'sAmerica's Most Innovative Companiesas noted by Fortune Consistently certified as great place to work A Leading Disability Employeras noted by theNational Organization on Disability Magnet® designated for the fourth consecutive time by theAmerican Nurses Credentialing Center (ANCC) We Embrace Innovation-Together. We believe in empowering our teams with the tools that help us work smarter and care better. That's why we support the responsible use of artificial intelligence. By encouraging innovation, we're creating space for new ideas, better outcomes, and a stronger future—for all of us. Comprehensive Job Description Provided Upon Request. Cincinnati Children's is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability #J-18808-Ljbffr Cincinnati Children's