QUALITY CONTROL ANALYST at ARTIVA BIOTHERAPEUTICS (2024-05 – Present)
- Performs NK cell and supporter cell line plate assays using the SpectraMax i3x Plate Reader
- Flow cytometric analysis of NK cells and T-Lymphoma cell line surface markers using the MACSQuant Analyzer 10, CytoFLEX and Cytek
- Bacterial endotoxin testing on drug product using the Charles River Endosafe
- Stability Program SME, Scheduler (Smartsheet, OnePager)
- QC Equipment Qualification Project Lead
SENIOR MANUFACTURING ASSOCIATE at POSEIDA THERAPEUTICS (2021-06 – 2024-01)
- Performed cell culture to produce allogeneic clinical material and process validations
- Used Miltenyi CliniMACS Prodigy to complete the selection and purification of target cells
- SME for Lonza's 4d-nucleofector system
- Trainer for gowning procedures, logbook documentation, and facility cleaning program
- Drives deviations to determine root cause and initiates CAPAs
- Completed a three-month internship with QA
CELL THERAPY SPECIALIST at KITE A GILEAD COMPANY (2017-11 – 2021-06)
- Performed cell culture to produce FDA approved YESCARTA and TECARTUS
- Used PAS-X MES for electronic execution, processing and resulting of batch records
- Used the ChemoMetec NucleoCounter and LIMS platform to enter verified cell counts and viability data
- Risk Assessment Program contributor for determining manufacturing job hazards and their risk scores
- Trained for regulatory agency inspections (FDA, EMA, Health Canada, and TGA)
QUALITY CONTROL ANALYST at CAPRICOR THERAPEUTICS (2016-08 – 2017-11)
- Performed single antibody staining on heart tissue derived cells for acquisition on the BD FACSCanto II
- Optimized and qualified test methods for routine QC testing, improving specificity and detection limits
- Managed batch sample testing with contract test laboratories for routine and method validation testing
- Trained new associates to perform routine QC assays
- Coordinated murine surgeries for all research departments
- Presented data to report trends and recommendations to QC analytical methods
MANUFACTURING ASSOCIATE at CAPRICOR THERAPEUTICS (2014-12 – 2016-08)
- Processed human heart tissue and their derived cells to produce a cell-based drug intended to treat myocardial infarctions
- Purified exosomes from supernatant using Millipore Centricon Plus Centrifugal Filters
- Proficient in environmental monitoring activities to determine whether a cleanroom is within ISO standards
- Knowledgeable in JMP statistical software for analyzing environmental monitoring data
- Initiating and updating clinical batch records and associated SOPs
