Rubisel Casanova

• Responsible for aseptic handling of reagents/products to ensure the

integrity and sterility of cellular products.

• Assist with change controls, WI, SOP’s, Deviations, and CAPA’s.

• Perform procedures In accordance with FDA’s GLP, cGMP,and GTP.

As well as standards set by other accreditation agencies.

• Perform cell growth and manipulation procedures such as cell

enrichment, cell culture, cellular product cryopreservation, cell

product thaw/wash.

• Maintained aseptic technique during processing to ensure quality and integrity of cellular drug products.
• Cleaned, prepared, and operated sophisticated automated cell processing for cell expansion of CAR-T clinical products including CliniMacs Prodigies, G-Rexes, LOVO, CUE, Cell Stacks, NC-200.As well as harvested and properly cryopreserved cells of CAR-T clinical products.
• Assisted in PD engineering runs for manufacture of clinical production.
• Responsible for training of new associates, gowning, aseptic technique/process simulations as well as keeping track of all manufacturing training which included observations and performances of processes to assist QA and upper management.
• Cross trained in TIL manufacturing to help with growing production while also working on CAR-T manufacturing.

• Monitored, cleaned, prepared, and operated equipment for cell processing of cell expansion of CAR-T clinical product in Grade C clean rooms.
• Assisted R&D (Vector team) with virus project for manufacture of clinical production.
• Revised SOPs to provide clear instructions to align with cGMP requirements and support efficient operations.
• Harvested and properly cryopreserved cells for R&D.

• Performed maintenance and ran standards on Novatia and HPLC equipment per standard operating procedures.
• Evaluated samples against standards by completing measurements, visual inspections and other established tests.
• Inspected raw materials and finished products to verify quality and quarantined items that did not meet quality requirements.
• Documented findings and entered into LIMS for tracking per Good Documentation Practices.

• Produced and updated lab documentation including records, logbooks and test procedures.
• Led team meetings with technicians and Lab Manager to discuss test results and status of tests in progress.
• Trained junior employees on proper line clearance procedures and handling of batch records and processes per ISO 13485 and ISO 9001 regulations.

• Set up, maintained and verified sterility of lab equipment and tools per standard operation procedure.
• Responsible for thawing, maintenance, harvesting, and cell expansion of human fibroblast cell cultures performance in biochemical assays.
• Implemented disinfecting procedure of 2% bleach from 70% Ethanol that reduced contamination.
• Performed proper cryopreservation of cells for future use.