Dr. Sujeet Shrivastava Email & Phone Number

Chandigarh, India

Chandigarh, India

Head of the Analytical R & D function. Analytical development of API’s molecules with multi-step chemical synthesis aiming at non-infringing routes.Method development and validations using HPLC, GC, LC-MS, GC-MS, XRD, PSD and ICP-MS techniques. Stability testing, Impurity profiling, and solid-state characterization for pharmaceuticals as per ICH guidelineRegulatory submission requirements and Analytical Queries on CMC submission for IND / NDA /ANDA and DMF filling.Isolation, purification, and characterizations of the related substance /Genotoxic impurities of API’sResolution of technical challenges and issues with CROs and other strategic partnersDevelopment of a system to track analytical lab operational efficiency and capacity utilization

Maharashtra, India

Overall responsibility of supervising day to day various analytical activities in support of API’s development- method development, validation, method transfer, stability study and regulatory filing.Coordinated with chemical research groups, quality control, production, and regulatory affairs of different units.Provided inputs for analytical problem-solving and review of change controls, and deviation related to ARD.Manpower and resources planning for ARD Laboratory. Supervise, and motivate, the analytical development team and ensure annual appraisal of reporters and ARD teamInvolved in complete analytical development of API’s, intermediates, and KSM and guided technical teams on DMF queries received from different regulatory agency

Bangalore, India

Head of the Analytical R & D function at Micro Labs Ltd. Management of analytical support function to Active Pharmaceutical Ingredients (API’s) - Regulated domestic and international markets.Overall responsibility of supervising day to day various analytical activities in support of API’s development- method development, validation, method transfer, stability study and regulatory filing.Provide inputs for analytical problems solving and review of change controls, deviation related to ARD.Work with pilot plant /quality team to release API’s for regulated market as per GMPBuilds and maintains strong working relationships with regulatory, quality and technical operation team Coordination with process development, business development, project management and with supply chain team on various analytical requirements. Review and implementation of SOP’s, STP’s and carry out laboratory investigations to identify the root cause in case of any regulatory queries

Bangalore, India

Headed the analytical R & D of Chemical development department for drug substance( DS)Manpower and resources planning for ARD Laboratory. Supervise, motivate, analytical development team and ensure annual appraisal of reporters and ARD teamDirected various analytical research team for method development and validations Analytical technology transfers. Coordinated with process technical group, Business development, Project management team and with supply chain team on various analytical requirements. Designed and directed all activities of analytical research and development in support of chemical synthesis and process development attended audio and video conference with various pharmaceuticals company on various analytical requirement

Bangalore, India

Directed various analytical research team for method development, method validations and method transfers. ICH stability studies and generation of specifications for drug substances and drug productsProvided analytical expertise and technical support during product scale-up and commercial manufacturing at in-house/ third party contract development organizationsCharacterization of impurities proactively in API’s, Intermediates and drug products using advanced techniques like LC-MS/MS etc. and their isolation

Greator Noida, Ncr Delhi, India

Maintained laboratory equipment and work areas to ensure compliance with SOPs, cGLPs, and ensured all analytical equipment's are in good working order and being used in accordance with guidelines.Designed analytical experimental plan for various requirement and critically analyzed data and information gathered in support of project directives.Managed the daily work distribution for scientist and guiding accordingly.Maintained record , scientific data and preparation, review & approval of Analytical control (AC),

Greator Noida, Ncr Delhi, India

Carried out analytical tests, maintained laboratory notebooks, collated data and writtten development protocols and technical reports.Provided practical support for solving technical problems and in house training of scientists on various protocols of STP’s, SOP’sDeveloped many analytical Method for the purpose of reaction monitoring, Impurities profiling and Assay of various intermediates and APIs for regulated markets using instruments like HPLC for more than fifty different projectTransferred the analytical technology with analytical control to QA/QC department of plant for the production of Intermediates and APIs

Tx, Usa

During my postdoctoral programme, I developed a methodology for the chemical speciation and bioavailability of organo- Arsenical species by LC-AAS hyphenated technique. I worked on a Comprehensive Quality Assurance and Quality Control Plan for Analytical Chemistry Laboratory and on In-Vitro protocol for the determination of chemical speciation and Gastro-intestinal bioavailability of organo arsenical species in different contaminated matrixes.

• Developed single and sequential extraction method for extraction of metals• Heavy Metal analysis by Atomic Absorption Spectrophotometer with Electro thermal, Flame and Hydride Generator Techniques.

New Delhi, India

Demonstrated the theory, use and operation of various instrumental methods of analysis: HPLC, GC,AAS, and Ion Selective Electrode etc. Mentor and inspired students to pursue postgraduate studies.Chemical speciation and bioavailability of metals in different matrix and extensive studies on Single and sequential extraction of metals

Jnu, New Delhi

Demonstrated the theory, use and operation of various instrumental methods of analysis: HPLC, GC, AAS, and Ion Selective Electrode etc.Mentor and inspired students to pursue postgraduate studies.Chemical speciation and bioavailability of metals in different matrixExtensive studies on Single and sequential extraction of metals

Postdoc (Pdf), Analytical Chemistry

Doctor Of Philosophy (Ph.D.), Analytical Chemistry

Master Of Philosophy (M.Phil.), Analytical Chemistry, Frist Class

PhD

Research Fellow, Chemical Research

Master Of Science (M.Sc), Organic Chemistry, Frist Class

Bachelor Of Sciences (B.Sc), Chemistry

BSc and MSc