Dr. Deepak Gupta Email & Phone Number

Woodstock, Md, Us

Durham, North Carolina, United States

• Team Leadership: Lead a team of scientists for method development and validation of different drug product using HPLC-UV and LC-MS/MS.• Method Development & Validation: Develop and validate methods for drug products, APIs, impurities, and other ingredients according to ICH/FDA guidelines.• Lab Operation: Responsible for maintained and calibration of different analytical instrument, like HPLC, UV, FTIR, LC-MSMS, GC• Sample Coordinator: Manage all sample which includes, stability sample from third party, sample from different project from client, inventory management • In Vitro Studies: Conduct In Vitro Release and Permeation studies of drug products like Cream lotion, gel, suspension on biological and Inert membranes utilizing HPLC/LC-MS/MS and Franz diffusion cells both manual and automation.• Audit Coordination: Work with the quality assurance unit to respond to site-wide audits, deviations, and out-of-specification events, ensuring compliance with regulations.• SOP Maintenance: Ensure Standard Operating Procedures and other quality documents are updated and maintained in coordination with the quality assurance unit.• Cross-Functional Coordination: Collaborate with Formulation Development, Quality Assurance, and clients for project management and progress tracking.• Project & Budget Management: Plan projects, manage capital expenditures (capex), inventory, and procurement of laboratory supplies and consumables.• Regulatory Submission Responsibility: Take responsibility for method development, validation, batch comparison, dose discrimination, and pivotal studies for FDA submissions as per current guidance

Mumbai Area, India

• Established state-of-the-art instrumentation facility in R&D for advanced research.• Collaborated with external labs, universities, and global suppliers to conduct research and develop product benefits.• Developed, modified, and validated analytical methods for analysing raw materials, products, natural products, byproducts, and impurities.• Ensured compliance with cGLP in Quality Control Laboratory.• Utilized modern analytical tools including GC, GC-MS, HPLC, LC-MS, LC-MS/MS, dissolution profiles, spectroscopy, and solid-state techniques (DSC, TGA, XRD).

Mumbai Area, India

1.Resposible for to generate Analytical Chemical Sciences & Measurement Sciences program for supporting Hair, Skin and Food Business.2.Planning and executing the research plans and support the analytical requirements for FMCG products which provides organization competitive edge.3.Resposible for collaborations with external agencies, Universities, National labs and Global suppliers (develop the competency within the company).4. Resposible to interface with development CQA, occassionally with manufacturing and marketing for smooth implementation of technology.5. Identify and track technology and competitor trends in analytical chemistry and be able to create strategic scenarios for new techniques in analytical science.6. Proteomic charactrization of protein by Nano-LC/MS/MS Techniques

New Jerey

• To design and develop bioanalytical assays, analyze samples from a variety of matrices, and interpret bioanalytical data in collaboration with and in support of Discovery and early development project teams.• Provide Bioanalytical support in PK, protein binding, drug distribution, and metabolism studies for compounds entering or in the clinical stage of development.• Responsible for analytical data review, data management, and table generation, as applicable in compliance with appropriate SOPs and regulatory agency guidelines. • Identifies resource needs and coordinates installation and maintenance of laboratory equipment and space.• Responsible for method development and validation as per ICH Guidelines.• Perform routine stability sample analyses, tests and experiments in accordance with GLP's, SOP's, and established procedures under direct supervision.• Understanding and following scientific procedures; operating automated instrumentation to process samples; and properly completing documentation and/or checklist(s) for each analytical test. Operate analytical equipment, such as HPLC's, GC and LCMS to analyze test samples. Coordinate with team in data review and documentation prior to management data review.• This review includes qualitative review of chromatography/spectra; and interpretation of data according to Standard Operating Procedures. Assist with maintenance and calibration programs for laboratory equipment.

New York, United States

• Method Validation & Documentation: Generated method validation/qualification and transfer protocols, summary reports, SOPs, and analytical test methods.• Problem Identification: Identified methodological issues in research protocols and implemented modifications to optimize experimental outcomes.• Standard Procedures: Established standard laboratory procedures and developed new protocols, ensuring accurate documentation of all experiments and projects.• Comprehensive Method Development: Conducted method development and validation for a variety of drug types (oral contraceptives, oral solutions, azoles, NSAIDs, banned IV drugs, and controlled substances) in compliance with GLP guidelines.• Standard Maintenance: Certified in-house standards and maintained logs for Reference and working standards.• Analytical Troubleshooting: Performed routine analyses and troubleshooting for instruments such as LC-MS, HPLC, GC, FT-IR, UV-Visible spectrophotometers, polarimeters, auto titrators, and Karl Fischer (KF) apparatus.• Laboratory Safety Compliance: Ensured adherence to laboratory safety protocols and proper handling of hazardous materials.