Provide leadership and guidance in the management of hospital laboratory. Maintain laboratory compliance with standards established by accrediting and licensing agencies. Initiate and participate in quality assurance programs as appropriate and support continuous quality improvement processes.

*Direct regulatory activities toward compliance and inspection readiness. *Provide laboratory leadership through participation in appropriate committees, staff, hospital departmental meetings, strategic planning, and goal setting. *Provide technical direction, mentoring and managing staff competencies.*Implement new policy and procedures.*Hire and retain department staff members. *Validate of new instruments, new Chemistry and microbiology assays.*Versatile and adapt to new needs such as implementation of COVID-19 rapid assay and re-emergence plan post pandemic.

Developed reagents and provided Tolerance limits for each component in assay for Chemistry analyzer ARCHITECT and ALINITY by ABBOTT

Responsible for generating QC data and performing similarity and stability studies from production stages of biosimilar drug for FDA approval. Responsible for authoring and executing Validation protocols for release and characterization of pipeline products and writing reports. Authors and reviews laboratory deviations, OOS results and investigations.

*Designed new tests: Urine Albumin and Albumin-Creatinine ratio, to target prediabetic/ diabetic population.*Introduced a new matrix system (Urine) for testing in otherwise repertoire of serum tests.*Developed assay for chemical analyzer, designed a kit for in-home use, tested for feasibility, usability of the kit, tested for robustness, accelerated stability of the test. In less than 6 months of starting the project the test is available to consumers by physician’s order.*Initiated Design Control documents, adapted all current assays to conform to the Design Control documents, in compliance to 21 CFR Part 820.30

Scientific consulting, Design of experiment, data analysis and interpretaion. Statistical analysis and authoring scientific reports.

Content writing for career placement in field of Science

Stem Cell Scientist/Senior Scientist, under contract, assisting in hematopoietic stem cell research within a manufacturing / R& D site. • Assignment focus is on the testing activity and functionality of cytokines made by HumanZyme on human cord blood stem cell. • Responsible for execution of ELISA based assay for cytokine activity and quality resulting in saving company revenue in shipping and storage costs of cytokines.• Assisted in the Quality Control Department and analyzed cytokine inventory thus dictating the production efforts.

Accomplishments include designing novel QPCR assay for testing purity of the API, included in certificate of analysis of released drug product. Responsible for conducting analytical development/validation of cell and non-cell based biological assays to support off-site manufacturing, on-site process development studies of API/FP, bio-formulation studies, and general characterization of biotechnology products. Worked on process development of Heparin. Involved in validation of Xa-IIa bio assays for potency determination of API. Manage IQ/PQ validation process for release of cGMP use laboratory instruments. Authored operational SOPs and URS/DQ for qualifying instruments. Participate within Tech Transfer team to improve existing ELISAs for blood glycoproteins. Extensive experience in cell and tissue culture.Essential Functions:·Involved in design, construction, purchase of instruments and commissioning of Cell and Molecular Biology (CMB) Laboratory to support new drugs in production facility.·Specified, purchased, and assisted in installation, validation, calibration of equipment for of CMB Laboratory including BINDER incubators, biosafety cabinets, iQ5 Real time PCR machine, BD FACS calibur, Milliflex Quantum rapid microbial detection system, Molecular Devices Spectramax, environment controlled chambers. Negotiated service agreements with vendors.·Assist in the development and validation of biochemical/biological and related assays for lot release and general characterization/similarity studies.·Design molecular methods to characterize and lot release of API.Responsible for all cell-molecular biology lab activities including but no t limited to designing and execution of experiments,compliance of instruments and general working and maintenance of laboratory. ·Critical review of laboratory data and perform instrument qualifications.·Performed IQ, OQ and PQ of newly bought equipment, utilizing both in-house staff and external contractors.

The PhD thesis project involved elucidating functional role of isoforms of transcription factor C/EBP epsilon (C/EBPe) involved in terminal differentiation of neutrophils and eosinophils. To determine the activities the human CD34+ progenitors were transduced with internal ribosomal entry site–enhanced green fluorescent protein retroviral vectors encoding the 32/30, 27, and 14-kDa C/EBPe isoforms, purified by fluorescence-activated cell sorter, and analyzed in colony forming assays and suspension cultures. We found C/EBP- isoforms could reprogram myeloid lineage commitment and differentiation consistent with their predicted activities basedon activator and repressor domains and in vitro functional activities. I gained extensive experience in handling and isolating and differentiation of human CD34 cord blood cells. Developed several stable and transient cell lines. Performed complex bacterial manipulation, protein and molecular biology experiments.Publications:Ellis A, Ackerman SJ, Crawford L, Du J, Bedi R, Denburg J. Cord blood molecular biomarkers of eosinophilopoiesis: kinetic analysis of GATA-1, MBP1 and IL-5Rα mRNA expression. Pediatric Allergy and Immunology, 2010 Jun; 21(4 Pt 1):640-8. Epub 2010 Mar 19.Kular RK, Yehiely F, Kotlo K, Cilensek Z, Bedi R, and Deiss LP. GAGE, an antiapoptotic protein binds and modulates the expression of nucleophosmin/B23 and interferon regulatory factor 1. Journal of Interferon and Cytokine Research. 2009 Oct; 29(10):645-55.Bedi R, Du J, Sharma AK, Gomes I, Ackerman SJ. Human C/EBPe isoforms differentially reprogram myeloid lineage commitment and differentiation. Blood. 2009 Jan 8; 113(2):317-27. Epub 2008 Oct 2.

In vitro propagation of Taxus sp