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Cell-Based Potency Lab Technician
Job Description
The Cell-Based Potency Lab Technician is a team member in the Large Molecule & Advanced Therapy Medicinal Products Services group.
Critical Performance Areas
■ Processing customer orders for release and stability testing of cell & gene therapeutics and biologics using cell-based potency assay testing, including complex sample preparation, according to both ISO and cGMP standards
■ Supporting the development and validation of cell-based potency assays
Essential Job Functions
■ Documentation of raw data, deviations, and Out-of-Specification result according to cGMP best practices
■ Care, qualification, and maintenance of equipment
Requirements
Bachelor’s degree in Cell Biology, Biochemistry or equivalent with a minimum of 2 years relevant laboratory experience.
■ Professional experience in a cGMP-regulated pharmaceutical environment is preferred.
■ Sound knowledge of cell culturing (human and mammalian cell lines).
■ Experience in ELISA, microscopy, and flow cytometry and cell sorting, and experience with UCP general chapters and monographs is encouraged
Other Desired Skills/Abilities
■ Knowledge of LIMS and data processing software (e.g. PLS 3.0, Gen5)
■ Commitment to be proactive, committed, reliable, hard working, team-oriented, and socially minded
■ Capable of working precisely and accurately
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