Data Scientist

Authored quality notifications in SAP to ensure accurate documentation and reporting. Conducted sterility testing within softwall/SKAN isolators. Created and updated Standard Operating Procedures (SOPs) using Veeva Vault. Performed neomycin potency testing of culture media for quality control. Executed bioburden and facility water testing using membrane filtration techniques. Led the execution of a penetration study for the qualification of a new sterility isolator load pattern. Demonstrated proficiency in GLIMS usage for efficient sample management and testing.

Conducted environmental monitoring of non-aseptic/aseptic production areas and personnel. Performed LAL testing of WFI, clean steam, and reverse osmosis water systems. Conducted water bioburden, microbial analysis, and total organic carbon testing. Performed particulate testing of final products, in-process beads, and vials. Identified vaccine microorganisms using gram stain techniques. Managed laboratory test results using a global laboratory information system. Conducted viability testing of un-lyophilized and final product.

Conducted environmental monitoring of non-aseptic/aseptic production areas and personnel. Performed LAL testing of WFI, clean steam, and reverse osmosis water systems. Conducted water bioburden and total organic carbon testing. Performed particulate testing of final products, in-process beads, and vials. Identified BCG using gram stain techniques. Managed laboratory test results and data in the global laboratory information system.