Prellis Biologics is a seeking a Sr. Lab Technician to drive the research and development of proprietary EXIS (External Immune System) technology and associated production infrastructure. The Sr. Lab Technician will be responsible for maintaining the preparation, disposition, and aliquoting of critical reagents as well as bulk isolating PBMCs and critical cell types for all incoming human donors.
Responsibilities:
Expected to work in a pre-manufacturing environment and have a basic understanding of traceability, good manufacturing practices (GMP), and standard operating procedures (SOPs)/work instructions (WIs).
Ability to follow SOPs and WIs as written and record the 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 (i.e. MultiMACS and RoboSep)
Batch cryopreserve PBMCs and critical cell types and maintain liquid nitrogen inventory
Recommends changes to improve production processes, equipment, product quality/yield, and supports 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.
Works cross-functionally with end-users (cell biologists, immunologists, engineering groups) to adequate 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.
Education and Experience Requirements:
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).