Dr. Sujeet Shrivastava

Dr. Sujeet Shrivastava Email and Phone Number

GM and Head- Analytical Research & Development @ Ind-Swift-Laboratories Ltd.
Dr. Sujeet Shrivastava's Location
Chandigarh, India, India
Dr. Sujeet Shrivastava's Contact Details

Dr. Sujeet Shrivastava work email

Dr. Sujeet Shrivastava personal email

n/a
About Dr. Sujeet Shrivastava

Ph.D with 21+Years of Experience in Pharmaceuticals R & D (Analytical Development)An accomplished manager and analytical development scientist by training with 21+ years of post-PhD industrial experience. I have held several positions of increasing responsibilities while working in various pharmaceutical R& D and top CRO’s in India, including more than 12 years of experience in leadership roles in the Analytical R&D (separation science, spectroscopic science, solid-state characterization, analytical technology transfer, regulatory filing and etc.) for active pharmaceuticals research. Expertise in regulatory guidelines (e.g. FDA, EMEA, EDQM, ICH, WHO), cGLP, cGMP practices, review of method development/ validation protocols/report for analytical chemistry laboratory and have successfully faced different Regulatory Audits (FDA & EMEA) and provided strategic inputs on technical requirements-Providing Scientific, regulatory, and business oversight of analytical projects. Strategic planning and execution of projects and processes within the ARD team.Talks about #Method development, #Method validation #Genotoxic impurities, #N-Nitrosamine impurity, #Chemical Characterizations ,#Regulatory deficiencies, #CROs, #Audit, #ANDA/DMF Filling/Query

Dr. Sujeet Shrivastava's Current Company Details
Ind-Swift-Laboratories Ltd.

Ind-Swift-Laboratories Ltd.

View
GM and Head- Analytical Research & Development
Employees:
182
Dr. Sujeet Shrivastava Work Experience Details
  • Ind-Swift-Laboratories Ltd.
    Gm And Head -Analytical R & D
    Ind-Swift-Laboratories Ltd. Jun 2023 - Present
    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
    View
  • Harman Finochem Ltd, Aurangabad, Mh, India
    Head - Analytical R & D
    Harman Finochem Ltd, Aurangabad, Mh, India Jun 2020 - Jul 2021
    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
  • Micro Labs Ltd.
    Gm And Head-Analytical R & D
    Micro Labs Ltd. Nov 2016 - Apr 2020
    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
    View
  • Syngene International Limited
    Agm/Group Leader, Analytical R & D
    Syngene International Limited Jun 2013 - Nov 2016
    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
    View
  • Syngene International Limited
    Senior Team Leader, Analytical Research And Development
    Syngene International Limited Aug 2011 - May 2013
    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
    View
  • Teva Api India Limited
    Sr. Research Scientist- Analytical R&D
    Teva Api India Limited Apr 2007 - Jul 2011
    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),
    View
  • Teva Api India Limited, Teva Pharmaceutical Company
    Research Scientist-Analytical Research And Development
    Teva Api India Limited, Teva Pharmaceutical Company Jan 2005 - Dec 2006
    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
    View
  • The University Of Texas At San Antonio
    Postdoctoral Fellow (Pdf)
    The University Of Texas At San Antonio 2002 - 2004
    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.
    View
  • Jawaharlal Nehru University And Council Of Scientific And Industrial Research, New Delhi India
    Research Associate(Ra)
    Jawaharlal Nehru University And Council Of Scientific And Industrial Research, New Delhi India 2001 - 2002
    • 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.
  • Jawaharlal Nehru University
    Senior Research Fellow (Srf)
    Jawaharlal Nehru University Aug 1997 - Jun 2000
    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
  • Jawaharlal Nehru University, New Delhi
    Junior Research Fellow (Jrf)
    Jawaharlal Nehru University, New Delhi Jul 1995 - Aug 1997
    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

Dr. Sujeet Shrivastava Skills

Hplc Analytical Chemistry Technology Transfer Lc Ms Uv/vis Validation High Performance Liquid Chromatography Gmp Glp Nmr Sop Organic Chemistry V&v Gas Chromatography Chemistry Pharmaceutical Industry Purification Laboratory Characterization Liquid Chromatography Mass Spectrometry Good Laboratory Practice Chromatography Uv/vis Spectroscopy Gc Ms Standard Operating Procedure Quality Control Pharmaceutics Research And Development Spectroscopy Ftir Spectrophotometry Medicinal Chemistry Process Simulation Formulation Organic Synthesis Method Development Nuclear Magnetic Resonance Wet Chemistry Tga Differential Scanning Calorimetry Powder X Ray Diffraction In Vitro Ir R&d Fda

Dr. Sujeet Shrivastava Education Details

Frequently Asked Questions about Dr. Sujeet Shrivastava

What company does Dr. Sujeet Shrivastava work for?

Dr. Sujeet Shrivastava works for Ind-Swift-Laboratories Ltd.

What is Dr. Sujeet Shrivastava's role at the current company?

Dr. Sujeet Shrivastava's current role is GM and Head- Analytical Research & Development.

What is Dr. Sujeet Shrivastava's email address?

Dr. Sujeet Shrivastava's email address is sh****@****o.co.uk

What schools did Dr. Sujeet Shrivastava attend?

Dr. Sujeet Shrivastava attended The University Of Texas At San Antonio, Tx, Usa, Jawaharlal Nehru University, New Delhi, Jawaharlal Nehru University, New Delhi, Indian Institute Of Technology (Banaras Hindu University), Varanasi, Department Of Chemistry, Banaras Hindu University (Bhu),varanasi, India, Department Of Chemistry, Banaras Hindu University (Bhu),varanasi, India.

What skills is Dr. Sujeet Shrivastava known for?

Dr. Sujeet Shrivastava has skills like Hplc, Analytical Chemistry, Technology Transfer, Lc Ms, Uv/vis, Validation, High Performance Liquid Chromatography, Gmp, Glp, Nmr, Sop, Organic Chemistry.

Not the Dr. Sujeet Shrivastava you were looking for?

View similar profiles

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.