Overview
We are seeking a highly skilled and motivated Commercial GMP/FDA Stem Cell Laboratory Technician to oversee operations. The successful candidate will possess extensive experience in commercial laboratory settings, with a strong emphasis on stem cell techniques and research. Must be willing to work in a collegial and collaborative manner with PhD Lab director. The ideal candidate will demonstrate exceptional technical expertise, and ability to work as part of a team.
Responsibilities
- Participate in daily laboratory operations, ensuring all procedures comply with Good Laboratory Practice (GLP), FDA regulations, and Current Good Manufacturing Practice (CGMP) standards.
- Oversee the preparation, culture, and differentiation of stem cells, utilizing techniques such as histology, molecular biology, and microbiology to support research and clinical trial objectives.
- Manage laboratory inventory, including reagents, consumables, and equipment maintenance, ensuring optimal functionality and compliance with regulatory standards.
- Comply with laboratory protocols for stem cell processing, analysis, and quality control testing in accordance with regulatory requirements.
- Coordinate data collection, analysis, and documentation while maintaining accurate records within Laboratory Information Management Systems (LIMS).
Requirements
- Proven experience working within regulated environments such as GLP laboratories or clinical laboratories adhering to FDA regulations.
- Extensive knowledge of laboratory techniques including stem cell culture, histology, molecular biology assays, microbiology methods, and laboratory procedures.
- Familiarity with CGMP standards applicable to cell therapy manufacturing or regenerative medicine products.
- Demonstrated expertise in data analysis, project management, and laboratory information systems (LIMS).
- Hands-on experience with microbiology techniques and clinical laboratory operations related to stem cell research or therapy development.
Job Type: Full-time
Pay: $26.39 - $31.78 per hour
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Initial Offsite Training is Required
Experience:
- Stem Cell Culture: 3 years (Required)
Work Location: In person