Umesh Kishnani Email & Phone Number

Philadelphia, PA, US

Philadelphia County, Pennsylvania, United States

Heading a team of 280+ personnel while driving capacity improvements and strategic planning. Working with the Philadelphia Site Lead on budgeting and resource management. Accountable for site performance key metrics coupled with continuous improvement drives. Assuring laboratory performance maintains and/or improves operational and financial efficiencies..

• Spearheaded a 68-personnel strong (and growing) team in a matrix work environment whilst directing end-to-end Laboratory operations for Research Grade, GMP-Source, and GMP products. Maintained accountability for.
• Out of Specification/Out of Trend/Aberrant Results
• Quality Events/CAPAs/Change Controls/Audit Responses’ status
• Root Cause Pareto Analyses
• Right First TimeChampioned multi-site enterprise project of LIMS institution for boosting electronic data records’ maintenance. Promptly introduced state-of-the-art rapid microbiological methods, namely Rapid Sterility.

Directed QC-Analytical Laboratory operations in Allendale, NJ and Mountain View, CA. Served as a Functional Leader for all Quality Control based activities. Led commercial readiness projects of raw material qualification and testing, stability, method validation, laboratory documentation, 21 CFR Part 11 compliance, and LIMS implementation. Liaised with.

Rensselaer, NY

Supervised routine testing for Early Phase molecules. Drove projects end-to-end in alignment with standards, timelines, and quality expectations. Coordinated internal/external resources to ensure assay completion for in-process, stability, and release studies. Provided planning and direction to QC-Analytical Sciences laboratory, testing, development, and.

Kenilworth, NJ

Member of the Forced Degradation (FD), Impurity Profiling, and Mass Spectrometry group within the Bioprocess Development division. Executed BLA-enabling late stage analytical characterization of Drug Substance (DS) and Drug Product(DP), mainly monoclonal antibodies (mAbs). Served as Subject matter expert within the FD group for several biochemical.

Kenilworth, NJ

Supervised, mentored, and championed a group of 15 scientists in a matrix environment to ensure project timelines were duly met, while working collaboratively with other early and late-stage groups. Sub-member of the Forced Degradation and Impurity Profiling group. Provided laboratory-intensive assistance in BLA-enabling late stage analytical.

Rahway, NJ

Assisted the direct supervisor and senior investigator in the research of new short interrupting RNA (siRNA) sequences to study RNA interference pathways. Performed synthesis, purification, characterization, and duplexing of DNA and RNA sequences for biological assays. Carried out numerous analytical testing on HPLC/LCMS/MS/CGE/MM192 DNA Synthesizers and.

Branchburg, NJ

Assisted Principal Scientist and Senior Scientist by managing Bioprocess HPLC machines used for protein purification in a cGMP environment. Collaborated with the synthesis department to lay out plans for efficient, timely synthesis and purification of nucleotide sequences. Gained experience with UNICORN software used for carrying out the chromatographic.

Master'S Degree, Business Administration And Management, General

Focus on Finance, Strategy, and Economics

Bachelors Of Science, Biomedical Engineering

Biomedical Engineering