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Biopharmaceutical Sciences
Expert is a skilled, highly motivated, dedicated, and result oriented scientist with vast experience & knowledge in bioprocess development & manufacturing of biopharmaceuticals. He is an analytical SME for bioassays, Immunoassays, Electrophoresis, HPLC, PCR and Cell Culture. Expert is an…
Translational Medicine and Biomarker Research in Cancer Drug Discovery
Expert is a Scientist with 8+ years of extensive hands-on experience and deep understanding of cancer biology with focus on chromatin, RNA, epigenetics and gene expression regulation. She is a leader of multiple projects with interdisciplinary collaborators, driving conceptualization, execution,…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Plant Cell Molecular Biology, Biochemistry, Bioenergy, Algal Biotechnology, Biomass Processing
Expert has a strong track record at internationally competitive level in plant cell molecular biology and biochemistry, mass spectrometry and proteomics, gene discovery and post-genomic systems biology and development of analytical techniques, achieved over 16 years of leading projects in…
Assay Development, Bioanalytical Chemistry, Validation, Intellectual property
The expert has extensive experience writing proposals, résumés, cover letters, CVs, grant applications, provisional patent applications and technical publications. Additionally the expert has experience in the areas of assay development, bioanalytical chemistry and food and agricultural products testing.The expert has…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…