GXP Specialist - Applied Gene & Cell Therapy Center

Primary Location

Location S

Applied Gene and Cell Therapy Center

Day (United States of America)

Full time

40

1

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.

• 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…