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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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