• Consultant and project management for life sciences and pharmaceutical companies. My clients are scientists, researchers, businesspersons, and consulting firms.
• Broad scientific and technical knowledge in life sciences - from basic (Molecular Biology, Biochemistry, Parasitology, Virology, Dermatology, Oncology, Immunology, Genomics, and Bioinformatics) to applied research (Development of Point-Of-Care Testing Device for the diagnosis of infectious diseases, Drug Discovery and Development and Cell Based Assay); well versed in associated technologies, their translation, and commercialization.
• A certified Project Management Professional (PMP®) from the Project Management Institute (PMI). I also obtained a course completion certificate for Pharmaceutical Canadian Regulations from
Regulatory Affairs Professional Society (RAPS).
• Through MBA and Certification in bioscience management, I developed skills in market research, product and business development and financial analysis for Life Sciences and Pharmaceutical industry.
• A thorough professional with an entrepreneurial drive, proactive attitude and capable of thinking in & out of the box.
Managed scientific research projects for product development. Developed point of care testing device based on nucleic acid detection for in vitro diagnostics of M. tuberculosis, C. difficile and Dengue Virus.
Co-ordinated with a team of scientists and engineers from academia (KECK Graduate Institute), non-profit organizations (PATH) and bioscience industry (Claremont Bio-Solutions) to develop a fully integrated, low cost, sample-in to answer-out point-of-care nucleic acid testing device.
Assay optimization and analyzing multiple parameters with the Design of Experiment (DOE) software. Root cause analysis tools to solve the problem.
Supervised and trained laboratory staff, students and summer trainees in the lab.
Validation of laboratory equipment, GLP, cGMP, Lean/Six Sigma, managing quality control, risk assessment (FMEA, cause and effect diagram) and regulatory compliance of products and devices. Perform and manage quality assurance, quality approval, change control, SOPs and document management system.
Manage scientific project and developed in situ molecular hybridization technique for the detection of Hepatitis C Virus RNA in liver biopsy samples.
Validation of monoclonal antibodies and polyclonal antibodies for the detection of cancerous tissue using immunohistochemistry technique. Prepares, reviews and various product-specific documents including product quality reviews.Validation of laboratory equipment, cGMP and quality control.
Worked with a research team and the product management team to successfully develop and commercialize products (Xmatrx, i6000). Evaluate product performance to mitigate the compliance issue.
Interacted with customers and tracks customer Key Performance Indicator quality metrics, resolved technical query and coordinated with the sales team for business development.
Administered the Laboratory Technicians and Research Associates.