Stutee Subba, Rac-Us Email & Phone Number

Chicago, Il, Us

United States

Lake Forest, Illinois

Performed method development, qualification/validation, and transfer studies to support biologics programs. Execute testing strategies for characterization of biologics products as part of biosimilarity assessments and to inform cell line engineering and process/formulation development. Developed, optimized and troubleshot methods for Cation Exchange Chromatography (CIEX), Size Exclusion (SEC) and Reverse Phase (RP-HPLC) methods, RP-HPLC with ELSD and SDS-PAGE methods to support process development.Trained scientist in Capillary Electrophoresis (CE) methods developmentMaintained and managed one database for all the stability data obtained from different sites for supporting BLA (Biologics License Application) submission.

Chicago

Supervised mentored, trained and developed lower level scientists and reported performance targets to senior managers. Developed analytical methods and authored technical reports and protocols to support analytical sections for regulatory submission.Involved in writing reports for reference standard qualifications, comparability and force degradation studies.Designated SME for electrophoresis-based methods (SDS-PAGE, IEF, western blotting, ELISA, CE-SDS and cIEF).Write reports for any deviations, Out of Specification and implement CAPA in collaboration with QA.Perform release and stability testing for in-process, drug substance and drug product samples.

Planned, developed and implemented scientifically well-designed ELISA, SDS-PAGE, western blot, size exclusion HPLC and Capillary Electrophoresis methods for Mabs and cytokines.Support downstream process for successful protein purification using analytical tools.Co-developed cell based assay, maintained and subcultured mammalian cell.

Chicago

Performed water system validation according to USP guidelines.Assisted in upstream process development, which involved fermentation, homogenization and harvesting of cell pellets. Authored and reviewed SOPs for equipment’s and standard analytical test methods.

Tutor student in biology and chemistry at the middle and high school levels. Planned lessons and curriculum and provided 1:1 support for students with a variety of learning styles and need. Plan and run parent tutoring meetings to facilitate at-home learning leading to student grade improvement.

Master’S Degree, Cell/Cellular And Molecular Biology

Master’S Degree, Specialization In Microbiology

Bachelor'S Degree, Biology/Biological Sciences, General

Bachelor'S Degree, Education