Implement and Improve Quality System, Set up release testing assays development and qualification, Write SOPs, training, and manufacturing process improvement, Liaison with USDA.

Responsible for Setting up Quality system,Testing methods and process control for veterinary vaccine product. Wrote Quality manual and SOPs, Set up In-process and final release testing methods and Quality control. Quality Assurance and Document control.

Manufacturing Operation inputs in Manufacturing of Native Viral Antigens, Cell culture process improvement, Purification and adjustment of Viral antigen, SDS Page, western blot, ELISA analysis for antigen adjustment, Training, Assay development, SOPs, Troubleshooting,

Laboratory Operations and Strategic leadership, Manage Night Operations of a Largest Vet. Reference laboratory with over 96 reports. Created metric based process tracking, Implemented 5S and Lean processes with a view of continuous improvement and projected growth.

To lead Manufacturing activity, To coordinate tech transfer from R&D, Clients and in-house projects, To create new product ideas with Sales and business development group, to coordinate efforts with materials management and finance to control Inventories and Scrap. To oversee ISO- GMP regulations are followed in manufacturing, keep Documentation updated. New product development, Design Control, Tech transfer

Managing workforce with manufacturing responsibility around $10+M a year. Responsibilites encompass Meeting production targets in time. Planning and scheduling more than 20 antigen products. Training, upstream and Down stream Process improvement, ISO/GMP compliance, Writing SOPs, Managing Work force of 12 technicians and 3 Product Managers.Other positions held at Meridian Lifescience inc. Manager, Cell Culture and Vet. Products; Managing Cell culture department, with 1 product Manager + 5 techs as direct reports Managing Veterinary diagnostic Kit production with 2 direct reports. Managing OEM antigen, Latex and recombinant Protein production. Trouble shooting, Process improvement, Investigations and mentoring new staff are other responsibilities.

Job Profile: Investigations, Transfer of technology to Operations, Process Development and Improvement.Initiate and develop protocols, execute/supervise and write final reports for investigations, method validation and process validation.Improve manufacturing process and product quality by developing and implementing methods to reduce variability and increase yields. Interact with Research and Development, Production, Quality Control, Quality Assurance and Regulatory Affairs to ensure product quality and other technical matters. To play active role in Quality Review Board (QRB), Production troubleshooting, and R&D meetings.Goals achieved in Last 6 months:Investigated the Immuno-fluorescent slide (IFA slide) problems. Improvised, implemented and trained Technicians for new production protocol. (Turned around the slide production process) Current Project : Production of Recombinant Viral antigens using recombinant yeast clones in 20 L Fermentor, fermentation and purification. Risk assessment for three different products/processes.Tech transfer for recombinant Protein production through yeast fermentation. Auditing facilities at both places, for the process followed by Process Validation (PV). Written several SOPs and revise documents pertaining to IFA Slide procedures. Written process documents for fermentation and protein purification processes.

To study Structural and functional aspect of cytoskeletal proteins with reference to focal adhesion complexes. It involved cloning, expressing, purifying, and crystallizing human cytoskeletal protein complexes for crystal structure determination and functional assays. Other duties: To manage lab resources, ordering, helping PI with budgeting, training junior members and troubleshooting, and equipment maintenance

Duties: * To manage lab resources, ordering, helping PI with manuscript, reports and presentations, training graduate students, troubleshooting and equipment maintenance.* To develop new project in the area of Barrier function and Permeability in Retinal vascular endothelial cells.Achievement: * Standardized the culturing of Micro vascular endothelial cells on porous supports.* Standardized the barrier function models for these cells. And collected preliminary data establishing changes in junction protein following different bioactive molecule treatments and Hypoxia.

Research in the area of tight junctions and signalling.To manage lab resources, ordering, helping PI with manuscript, reports and presentations, training graduate students, troubleshooting and equipment maintenance

1.Worked on mechanism and archetecture of barrier function in intestinal epithelial cells, signalling associated with barrier function in oxidative stress and alcoholism. The Following is repsentative list of key publications.2 Protein phosphatase 2A plays a role in hydrogen peroxide-induced disruption of tight junctions in Caco-2 cell monolayers.Sheth P, Samak G, Shull JA, Seth A, Rao R.Biochem J. 2009 Jun 12;421(1):59-70.3 Sheth P, Delos Santos N, Seth A, Larusso NF, & Rao RK (2007)Lipopolysaccharide Disrupts Tight Junctions in Cholangiocyte Monolayer by c-Src, TLR4 and LBP-Dependent Mechanism.Am J Physiol Gastrointest Liver Physiol. 2007 Apr 19; PMID: 174463084. Seth A, Sheth P, Elias BC & Rao RK (2007)Protein Phosphatases 2A and 1 Interact with Occludin and Negatively Regulate the Assembly of Tight Junctions in the CACO-2 Cell Monolayer.J Biol Chem. 282:11487-11985. Sheth P, Seth A, Atkinson KJ, Gheyi T, Kale G, Giorgianni F, Desiderio DM, Li C, Naren A, & Rao RK (2007)Acetaldehyde dissociates PTP1B-E-cadherin-beta-catenin complex in Caco-2 cell monolayers by a phosphorylation-dependent mechanism.Biochem J. 402:291-300Plus 6 more paper published between 2003 -2006

To manage lab resources, ordering, helping PI with manuscript, reports and presentations, training graduate students, troubleshooting and equipment maintenance.; and other proteases and their role in asthma and inflammationa) Worked on role of mast cell Tryptase and regulation of tryptase activation ex vivob) Studied role of mast cell enzymes in regulation of mucin secretion in bronchial epithelial cells (A549, H292, 16HBE). Role of PARs in mucin secretion and up-regulation of MUC genes.Project involved the following techniques:* Real time PCR* Mast cell and epithelial cell culture - both primary and cell lines,* Evaluation of pharmaco-chemical inhibitors of mast cell tryptase activation* Flow cytometry* Extraction and purification of mast cell tryptase from human Lungs* Development of ELISA assay for Mucin (muc5AC)

Teaching Biochemistry and Biotechnology at an undergraduate level.Supervising research in the area of plant tissue culture and training students on mocked or simulated industrial units in plat biotechnology* Research of rat skin tryptase: purification and characterization* Plant tissue culture and protoplasting and transformation of plant cells* Training biotech students on entrepreneurship module

Incharge- Research officer in Cell and Molecular Biology Division in the Research and Development Section. Supervised a team of five members working on * Cloning and expression of insulin and bovine Growth Hormone (bGH),* Immunodiagnostic products mainly Elisa based * Protoplast fusion and strain improvement of antibiotic producing streptomyces strains* Optimization and Scale up of Rifamycin fermentation conditions