SR SPECIALIST-GXP - Translational Trials Development and Support Laboratory (TTDSL) - Translational Core Labs (TCL)
Cincinnati Children's Hospital Medical Center
Location: Cincinnati, Ohio
Academic / Research
Internal Number: 134252
SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.
Provide supervision; training and mentoring to team members. Development; technology transfer; scale up; manufacturing/processing/ and or testing; Qualifications and validations. Analyze data and assist others. Write deviations; participate in external and internal audits. Customer support.
???Manufacturing Perform or supervise activities, GxP production, 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. Analyze data, perform statistical and graphical analysis of data, and interpret results. Modify and adapt new procedures as requested. Maintain current knowledge of manufacturing/analytical techniques and industry practices. Identify and adapt new manufacturing and analytical methodologies to enhance current capabilities. 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 integral 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 Oversee and perform day-to-day Translational Core Laboratory operations including cleanroom facilities maintenance, project management, and fee-for-service support as assigned. Troubleshoot and correct erroneous results or problems with laboratory equipment. Maintain and repair equipment; monitor proper use by personnel. Maintain inventory of laboratory supplies and equipment; order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report equipment failure or 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. Assist in preparing, writing, and maintaining project budgets and timelines. Maintain required documentation systems. Monitor expenditures and prepare core billing summaries for services rendered. Communicate with external vendors to obtain technical information as needed. Communicate with collaborators to discuss processes, or assay conditions, and troubleshoot when required. Provide written and oral reports to management on a regular basis. Prepare internal regulatory applications for IBC, IACUC, etc.. Perform other duties as assigned.
???Process Improvement Create, review, revise and follow Standard Operating Procedures, Protocols and Master Production and Control Records. Assists with internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and laboratory procedure requirements. Cooperate with and lead performance improvement initiatives and other compliance activities. Interact with QA to coordinate manufacturing and testing activities (i.e. production suite cleaning schedule, issuance of batch record, etc.). Participate in the efforts to achieve compliance with all Federal and State accrediting agency requirements. Perform all regulated activities strictly according to SOP. Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks. Maintain required proficiency and competency requirements.
???Training & Development Supervise direct and indirect reports and lead project teams as assigned. Provide assignments, direct supervision, training and mentoring to team members. Ensure staff meets requisite compliance and documentation requirements. Train laboratory personnel on proper laboratory and compliance techniques. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. Provide input and feedback on hiring decisions, professional development and performance management. Provide supervision to direct report(s), if any. Lead multidisciplinary projects as assigned and ensure project timelines are met.
???Bachelor's degree in a related field ??? 5 - 7 years of work experience in a related job discipline.
At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a 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.