Asiana Galarpe
Senior Specialist, Msat Cell Therapy and Engineering Support, Investigations Team @Bristol Myers Squibb
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WORK HISTORY
Senior Specialist, Msat Cell Therapy and Engineering Support, Investigations Team @Bristol Myers Squibb
Bothell, WA, US
The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating Minor, Major, and Critical deviations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. Responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring.
EDUCATION
University of Washington
Bachelor of Science - BS, Biology, General
University of Washington
Bachelor of Arts - BA, Health Studies
ABOUT ASIANA GALARPE
Current role involves investigating deviations in a clinical and commercial regulated GMP facility that manufactures CARs (chimeric antigen receptors) to reprogram T cells from a patient’s immune system to recognize and attack cancer cells. Self-motivated, passionate, and innovative bioengineer with an educational background in pharmaceutical bioengineering and professional experience in manufacturing. Strong analytical and communication skills with the passion to drive process improvement- cGMP biologics cell culture manufacturing of CAR-T cells for cancer immunotherapy- Aseptic processing in ISO 5 Biological Safety Cabinets- Specializes in the activation and transduction of T-cells, cell expansion using incubators and single use bio reactors, cell washing processes, cell separation techniques, and formulation of drug product- Writing and editing manufacturing SOPs, Batch Records, Training Documents, and Work Instructions to comply with cGMP requirements- Working with Quality, Science, & Technology team to initiate, QA Assess, and investigate deviations - Trainer and daily reviewer of electronic and paper Batch Records- Knowledge and first-hand experience of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
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