Marcela Escudero

MBA graduate and biotechnology professional, specializing in cell therapies and assays. 10+ years' industry experience with roles in Manufacturing, Quality Assurance and Control, Product Development and Translational. Strong quality mindset with a focus on spearheading resolutions for deviations and quality issues.

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

Master of Business Administration – CALIFORNIA STATE UNIVERSITY, LOS ANGELES (2020)

Certificate in Biotechnology Engineering – UCLA EXTENSION (2019)

Course – BD FACSCANTO II RESEARCH OPERATOR COURSE (2016)

Bachelor of Science in Biology & Minor in Chemistry – CALIFORNIA STATE UNIVERSITY, LONG BEACH (2013)