Thanh B. Email & Phone Number

United States

QC Senior Scientist - Incoming CAR T

Implemented, consulted, and managed the Raw Material program in a cGMP phase 1 environment. Guided the sampling room and inventory warehouse buildout to meet cGMP, FDA, and EMA regulation requirements. Managed outsourced testing of finished and stability products at Contract Manufacturing Organizations (CMOs). Created a raw materials program by.

Technical management of the QC laboratory including supervision of 11 QC Scientists. Served as the subject matter expert on the raw materials program with manufacturing and production planning. Ensured implementation and maintenance of quality systems within the QC laboratory met cGMP, FDA, and EMA regulations.Managed the sampling room buildout to reduce.

Continue to test raw materials while maintaining raw material programAssigned test procedures to QC and Microbiology analysts for testing of raw materials and stability and finished products.Updated SOPs on a bi-annual basis.Cross trained QC personnel on compendial and in-house testing for raw materials.

Morris Plains, NJ

Analyzed incoming raw materials for multi-compendia specificity and performed analytical tests to support manufacturingTested raw materials to verify purity and identification via current USP, EP, and American Chemical Society (ACS) compendia.Cross trained to maintain cell culture lines to support cell culture assay development.Maintained equipment and.

Bronx, NY

Analyzed stability and finished product testing of OTC topical samplesConducted analytical testing and research of drug substances, drug products and related compounds.Performed wet chemistry techniques such as Karl Fisher water determination on products to detect percent moisture.Utilized SAP system to register, manage and generate reports for sample.

South Plainfield, NJ

Analyzed native enzyme raw material, in-process, stability and finished product of sterile injectablesPerformed HPLC, UV/Vis, and in-house methods to detect drug potency, concentration of known in-process impurities, protein concentration, and enzyme activity of product on all batches.Assisted in the development and validation of analytical methods for the.