GXP Technician II - Applied Gene & Cell Therapy Center - Vector Production Facility
About The Position
The GXP Technician II role is within the Applied Gene & Cell Therapy Center at the Vector Production Facility. This position involves performing manufacturing/processing activities, process development, quality control, and high complexity analysis following established SOPs and protocols. The role requires meticulous record-keeping for GxP compliance, maintaining cell cultures, designing and executing daily laboratory work, and analyzing data. The technician will also be involved in day-to-day translational core laboratory operations, including cleanroom and equipment maintenance, ordering supplies, and responding to equipment failures. A high level of integrity, adherence to SOPs, and cooperation with quality assurance are essential. The role may also involve assisting in training laboratory personnel and mentoring junior staff.
Requirements
- Bachelor's degree in a related field
- 0+ years of work experience in a related job discipline
- Regulated manufacturing processing, testing and other related tasks
- Analyze data
- Equipment maintenance
- Record-keeping
Responsibilities
- Perform manufacturing/processing activities, process development, 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.
- Maintain cell cultures.
- Design and execute daily laboratory work.
- Analyze data, perform statistical and graphical analysis of data, and interpret results.
- Understand the scientific principles involved in the research and work being performed and apply those principles to improve techniques as appropriate.
- Maintain an active role in laboratory's meetings, presentations, and publications.
- Contributes material for reports, publications, journal articles, and abstracts.
- 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.
- 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.
- Report facility and equipment failure and alarms to laboratory management or QA team.
- Perform work with a high level of integrity and honesty.
- Practice a high level of integrity in maintaining confidentiality.
- Maintain required documentation systems.
- Willing and able to assist in daily operations of the laboratory including answering phone, organizing and cleaning of laboratory.
- Provides appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.)
- Perform other duties as assigned.
- Follow Standard Operating Procedures (SOP) and protocols.
- Cooperate with performance improvement initiatives and other compliance activities.
- Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance.
- Perform assigned duties strictly according to SOP.
- Maintain required proficiency and competency requirements.
- Assist in training laboratory personnel.
- May 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.
Benefits
- Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
