Debra Betchy Email & Phone Number

Rhode Island, United States

Cambridge, Massachusetts, Us

North Chicago, Illinois, Us

Promoted to Analyst III position. Maintain human cell lines and perform routine cell-based potency testing for final product, release, and stability samples. Trained in Cytotoxicity Assays, Binding ELISAs and ADCC. Author and review of SOPs, reports, investigations, and CAPAs. Acting as lead analyst for transfers and participating in the qualification of cytotoxicity assays. Executed qualification of Antibody Dependent Cell Cytotoxicity (report gene assay). Brainstormed with colleagues to trouble shoot cause of inconsistent results, resolving the issue by pooling and heating the reagent to a consistent temperature.• Conduct Bi-weekly maintenance of multiple cell lines. (6-10 human cell lines)• Perform approximately 50% of routine QC testing in Bioassay lab• Perform 8-10 different Specific Cytotoxicity assays, ELISA binding assays and Antibody Dependent Cell Cytotoxicity (reporter gene assay)• Served as Lead Analyst for transfer of cell-based potency assays• Trained other analyst on aseptic technique, cell culture and cell-based assays• Execute optimization and Cryopreserving of QC working cell banks• Conduct troubleshooting of problems with cell maintenance, assay performance, and laboratory equipment • Wrote and revised SOPs, CAPAs, Deviations, change controls, and investigations• Receive, aliquot and log stability samples into testing database (LIMS and SharePoint) • Participated in cross-functional safety committee• Researched, evaluated and purchased capital equipment• Investigate and annotate equipment alarms in Metasys• Maintain inventory of lab reagents and consumables, purchasing, aliquote, label, store and enter into CISPro

North Chicago, Illinois, Us

Promoted to the Analyst ll position continuing to perform routine cell-based potency testing for release, final product, and stability samples in addition to taking on additional responsibility for areas including ELISAs, documentation of SOPs, reports, investigations, and CAPAs. Maintained testing schedule for cell-based assays. Lead person for the transfers and participated in the qualification of cytotoxicity assays. Conducted comparison study of manual vs. mechanical cell counting, resulting in procedural change allowing mechanical cell counts when performing cell based assays.

North Chicago, Illinois, Us

Performed routine cell-based potency testing for in process, final product, and stability samples. Maintained multiple cell lines and participated in transfer of assays. Maintained inventory of lab reagents and consumables, Aliquot, labeled, stored, and entered lab reagents into CISPro. Coordinated and implemented transfer of master cell bank into cyrofreezer including detailed records of vial placement, transfer time, log book for master cell bank and purchasing of equipment.

Boston, Massachusetts, Us

Within the manufacturing facility, performed all tasks in a cGMP compliant environment supporting clinical and commercial processes. Prepared media and buffers and performed CIP and SIP of equipment to support manufacturing process. • Coordinated material transfer from the warehouse to manufacturing areas. • Operated, standardized, and cleaned the weigh booth.• Assembled and autoclaved spinner flask, tubing, and valve setups and base cans to support manufacturing processes.• Participated in the IQ, OQ, and PQ of glass wash / autoclave and media rooms of the commercial manufacturing areas. • Trained in preparation of thermocouples. • Assisted outside vendors during validation of autoclave and parts washer and execution of steam sterilization test for validation of media prep filter carts.