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. Liaising with Site Lead to develop long-range plans for equipment, facility needs, and personnel. Charting growth and career development for the Operational Team Leaders. Champion drives for effectuating systems that track personnel technical competency within various analytical testing departments. Direct and re-direct subject matter experts for ongoing client support and solutions for unmet needs in the Cell and Gene therapy space.

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 leading the Analytical Method Development, Method Validation, QC In- Process, Release, Environmental Monitoring, and Stability teams. Headed all facets of Quality Control for release of critical raw material/drug substance including, but not limited to, plasmid DNA, mRNA, enzymes, and protein modalities. Maintained and reported Quarterly targets to Senior Executive Team, including detailed analyses for under or over-performance of said objectives. Championed organizational Quality focus toward technological advancements by investing in cutting edge technologies such as Growth Direct Systems for Environmental Monitoring and Bioburden requirements. Participated in Technology Transfer drives for new products. Developed, assessed, and reported Quality Control metrics including, but not limited to:• 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 and Rapid Mycoplasma-PCR for swifter product release. Aligned Analytical Method Validation and Stability Programs in accordance with ICH guidelines. Established consistency in the choice and implementation of test methods by affording standardization of release panels. Steered complex projects in partnership with IT for ensuring 21 CFR Part 11 compliance and Computer System Validations (CSVs) of all GMP laboratory instrumentation.

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 Process Development, Analytical Development, and Manufacturing Sciences and Technology groups in Allendale and Mountain View along with Operations and other stakeholders. Drafted and presented latest estimates of monthly budgets to Finance. Planned and drove Quality Control activities based on allotted annual budget and approved capital expenses. Liaised with Process & Analytical Development as required to develop and qualify/validate new test methods. Carried out analytical gap assessments and ensured that existing methods used in the QC Laboratories were properly qualified/validated. Provided expertise in efforts to introduce consistency in the choice and implementation of test methods and interpretation of testing data. Harmonized QC lab testing equipment, methods, and testing standards employed globally. Steered projects with IT to ensure laboratory instrumentation across North American Hitachi Chemical sites were GMP qualified and 21 CFR Part 11 compliant. Managed QC Technology Transfers activities including but not limited to review/approval of transfer documents, method transfers from Analytical Development/MSAT to QC, method transfers between sites. Collaborated with Manufacturing Operations and Development at various sites, while providing support for process verification/comparability/qualification/validation documents as needed. Championed efforts with the Training Group to develop proficiency training for laboratory analysts. Assessed, developed, and reported Quality Control metrics including but not limited to Out of specification/Aberrant results, Deviation/CAPA/Change Control/Audit Response status.

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 research projects in abidance with regulatory compliance and support product development/release objectives. Offered knowledge of cGMP, FDA, ICH, and global regulatory requirements combined with hands-on R&D background. Offered technical guidance to lab personnel and conduct technical and performance reviews. Served as an SME in root cause analyses and impact identification for OOT, OOS, and atypical result investigations. Managed various quality compliance functions, namely Training, Document Control, Change Management, Validations, Audit-readiness, Quality Operations, Stability, CAPA, Investigations, Management Notifications, Quality & Efficiency Metrics and Process Enhancement to ensure an efficient and cost-effective operations in the interest of shorter product release times, compliance, and high first time right rate. Developed new processes for for measuring meaningful analyst and reviewer metrics which resulted in marked productivity and performance improvement.

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 characterization assays, namely all U/HPLC-based purity assays (SEC, HIC, RP, IEX) , capillary gel electrophoresis (CE-SDS), UV-Vis spectrophotometry. Served as an author, data reviewer and verifier for forced degradation and impurity characterization technical reports and addendums for mAb projects (KEYTRUDA being the most notable one). Gathered knowledge and working practice of biophysical characterization assays, namely DLS and SEC-MALS. Led efforts to align cross-team workings by adopting ELN template utilization and identified analytical leads and stakeholders from different divisions within the company to ensure change management.

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 characterization of Drug Substance (DS) and Drug Product (DP). Evaluated and documented analytical data for several biochemical characterization assays, namely all HPLC-based purity assays (SEC, HIC, RP, IEX) , capillary gel electrophoresis (CE-SDS), UV-Vis spectrophotometry.

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 Symyx robots. Obtained mass spectrometry readings to characterize the synthesized sequences. Managed and operated Agilent HPLC systems to obtain the anion exchange and reverse phase chromatography results. Merged final results of synthesis runs, mass spectrometry, and chromatography into electronic laboratory notebook (ELN). Presented and planned future sequencing measures based on the results obtained upon completion of studies. Researched on effective ways of shortening analysis time for purified single strands.

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 process for purification. Obtained UV/Visible and mass spectrometry readings to analyze results of the preps being performed and aliquoting the final products. Prepared batch records being sent out for clinical research and medical purposes. Recorded all the relevant data in LIMS upon completion of each batch record. Updated SAP with the inventory used in the purification process.

Master'S Degree, Business Administration And Management, General

Focus on Finance, Strategy, and Economics

Bachelors Of Science, Biomedical Engineering

Biomedical Engineering