Senior Laboratory Technician
1 week ago
Prellis Biologics is seeking a highly skilled Senior Laboratory Technician to drive the research and development of proprietary EXIS (External Immune System) technology and associated production infrastructure.
Key Responsibilities:- Work in a pre-manufacturing environment and maintain a basic understanding of traceability, good manufacturing practices (GMP), and standard operating procedures (SOPs)/work instructions (WIs).
- Follow SOPs and WIs as written and record necessary information in a batch record stored in an electronic lab notebook.
- Aseptically prepare sterile cell culture media, reagents, and buffers needed for critical workflows.
- Bulk isolate PBMCs from Leukopaks and continue cell separation into specific cell types with automated cell separation machines.
- Batch cryopreserve PBMCs and critical cell types and maintain liquid nitrogen inventory.
- Recommend changes to improve production processes, equipment, product quality/yield, and support the development of DOE-type studies and methodologies for measuring and verifying the impact of changes.
- Use a risk-based approach to implement changes and understand implications of changes on downstream processes and users.
- Work cross-functionally with end-users (cell biologists, immunologists, engineering groups) to capture process requirements.
- Maintain and report inventory on critical reagents and perform regular checks to dispose of any expired reagents.
- Execute validation testing for key company metrology.
- Help manage and catalog Material Safety Data Sheets (MSDSs) in collaboration with the operations and engineering departments.
- Minimum of AA, certificate program, comparable training, or higher with 10+ years of experience in hands-on wet lab techniques for manufacturing, cell separation techniques, and disposition and labeling of critical reagents.
- Experience with mammalian cell culture techniques, flow cytometry, single B cell antibody workflows, and protein/particle formulation and analysis techniques is a plus.
- Proficient using Microsoft Office applications and SharePoint.
- Understanding of quality systems as they related to production operations is a must.
- Lean manufacturing would be a plus.
- Experience working with ELN (Electronic Lab Notebooks).
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