Researcher, pharmacologists, operational experience in Preclinical and early stage discovery with leading pharmaceutical companies provided extensive background and hands-on drug discovery & development, operations, research and discovery experience. Starting at BITS, Pilani and Christian Medical College & Hospital, Zydus Cadila, Alembic Ltd and contract research organization (CRO) BioArc and GVKBIO developed and led cohesive and collaborative global multidisciplinary teams and established and directed pharmacology, DMPK and toxicology early discovery efforts and contributed towards candidate selection. Proven capabilities in budget, resource management, and approaches challenges with enthusiasm and determination, foster and maintain strategic partnership, leadership teams and external collaborations.

To develop strategic research plan to achieve organic and inorganic growth for biology business.Responsible to recognize the revenue by interaction with sponsors and achieve targeted profits. Customer satisfaction and relationship management. Manage Regulatory compliance Team building and productivity improvementPreclinical profiling of molecules for sponsor from hit validation to candidate selectionWork with cross functional teams of medicinal chemistry and Informatics. Work closely with business development/sales/proposal team across service areas. Actively participate in decision making to enable the early discovery support programs.Costing for the projects support and provide business intelligencePreparation and submission of Request for proposal for early discovery studies to sponsorsProvide scientific & technical oversight /management for studiesDirect and manage the scope of work, objectives, timelines and quality of deliverables for client in a cost effective manner. Meet the changing demands which accompany the simultaneous pursuit of multiple projects.Responsible for client audits/AAALAC on facility and studies pertaining to animal facility, pharmacological studies, and DMPK, toxicity/safety studies and bio-analytical laboratory. Established High Throughput (HTS)-ADME bio-analysis and Watson LIMS for early DMPK studiesEstablished pharmacological models in the area of pain (neuropathic pain) and inflammation (auto-immune diseases) and metabolic disorders. New pharmacological procedures for animal experiments-Planning of new laboratory infrastructure needs based on the outsourcing needs.Identify and develop contingency plans to manage the risk. Review SOP and implementation of documentation as per global standards, Interact with Other CRO for expansion of activities like formulation, large animal study and GLP toxicity studiesEvaluate potential new acquisition targets and strategic partnerships, joint ventures and alliances.

• Responsible for the overall management of R&D client pre-clinical projects and execution in compliance with company policies and regulations. Responsible for bioequivalence division to support BA/BE studies of generic drugs.• Formulate and harmonize project scopes, plans, strategies and budgets for R&D pre-clinical projects. Accountable for all project budgets and cost-savings considerations.• Recognize potential issues like technical, budgetary, and personnel related within the pre-clinical program that support the functional areas within R&D and make decision on solving the problem.• Responsible to work with project teams to assure the quality, timeliness and delivery of the various milestones encountered when developing new compounds. Demonstrated skills to form and lead high performing work groups to execute projects.• Direct interaction with client in conducting pre-clinical pharmacology, DMPK, Bio-analysis, and toxicological studies that to lead pre-clinical drug development.• Manage all components of a pre-clinical pharmacology group, including scientific staff, operations, protocol design, and authoring of reports submissions. • Keep up to date on outsourcing trends in the pharmaceutical industry.• Project Undertaken for Big and Small Biotech and Pharmaceutical Companies

Animal House Breeding and Maintenance: Direct and Oversees the activities of animal house activities of breeding, maintenance and supply of laboratory animals to various discovery projects for the evaluation of efficacy, toxicity and pharmacokinetics as per regulatory guidelines. Reviews animal care protocols and serves as a Chief Investigator of the Institutional Ethics Committee. Maintain standards, policies and procedures Oversees the development and maintenance of record keeping systems. Monitor staff operations and provides direct veterinary care for the animal house facilityPharmacology/DMPK studies• Method Development and Validation of analytical methods for new chemical entities using various biological matrix. (Plasma, urine, CSF, Bile, and Tissues) by LC MS-MS. To develop & optimize Bio-analytical methods for various drugs & their metabolites in Human Plasma, Serum and Urine.• Review and approval of SOPs related to instrument, procedures. Planning, implementation and conductance of a project as per protocol, SOP. Supervision and Monitoring of instrument validation and maintenance • Validation for execution of metabolite profiling for metabolite identification. Metabolite confirmation using in-vitro and in-vivo models. Bio-analysis of urine and quantification of the drug and metabolite.• In-vitro ADME profiling: Aqueous solubility, pKa and Stability of drug in Biological matrix. • PK/PD relationship studies • cytotoxicity assays using HepG2 cell line• in-vitro genotoxicity assays using CHO cell line like chromosomal aberration and micronucleus test.• Efficacy/Screening Models in the area of infectious disease mainly bacterial and fungal like pneumonia, thigh infection, skin abscess, UTI and virulence testing. • Models in the area of pain mainly neuropathic pain and inflammation models like Arthritis, IBD, Atherosclerosis model development