Sudipta Basu

Experience Bioanalytical And Clinical Pharmacokinetics Scientist
Singapore, Malay Peninsula, Singapore
Pharmacist, Biomedical Scientist, Analytical Chemistry
About
Global Clinical Director, responsible for clinical candidate proposals, critical clinical decisions, priority setting, study design, cost and timeline for various global studies. Develop state of the art clinical development programs for various compounds in compliance with applicable laws, regulatory guidelines, quality standards and company policies. Hands on experience in LC-MS/MS, ELISA, Small and Large molecule bioanalysis and Pharmacokinetics. Having a very good understanding of Biosimilar
Talents
Work Experience
Global Clinical Director, Singapore
Full Time Aug-2016 To present 8 years 8 months
Responsibilities
  • Working as a Global Clinical Director, responsible for clinical candidate proposals, critical clinical decisions, priority setting, study design, cost and timeline for various global studies. Develop state of the art clinical development programs for various compounds in compliance with applicable laws, regulatory guidelines, quality standards and company policies.
    The clinical pharmacology and bioanalytical department of EPD (Established Pharmaceutical Division) are responsible for handling phase I studies for BE, BA, PK, PD, safety, DDI, Food Interaction, Bioanalytics, Special Populations, Late Phase Clinical Pharmacology, population PK.
    Provide support for bioanalytical method development, method validation, sample analysis, reporting, central lab, kits supplies and laboratory manual preparation for various global clinical studies. Product dossier preparation and support for various countries. Population PK, PK/PD & IVIVC support.
Associate Director-Clinical Development
Dr. Reddy's Laboratories Ltd. Hyderabad, India
Full Time Dec-2013 To Jul-2016 2 years 7 months
Responsibilities
  • Worked as as Associated Director-Biologics-Clinical Development (CD). Managed three verticals - Act as a lead for Clinical Trial, Lab Operations lead and NBE program lead from CD at Dr. Reddy’s Laboratories, Hyderabad.
    Clinical Operational lead for CT: Strategy, Investigator/CRO selection, CDA/contract/MSA execution, Protocol, ICF, CRF preparation, execution of biosimilar clinical trials, CSR, regulatory, monitoring, budget and expenses, CSR finalization etc.
    Lab Operation Lead: Overall responsible for all biosimilar CT sample analysis, method validation (PK, ADA, Nab, PD etc) identification & selections of CRO, audit/monitoring, technology transfer and coordination of out-sourced clinical trials bioanalysis in various global CRO, selection of diagnostic/safety-central lab, sample movement and logistic, budget/invoicing, planning and strategy.
    New Biological Entity (NBE) Development: Act as a clinical development and lab lead for new biosimilar/bio-better development program.
Head-Bioanalytical, Analytical and Radio-lab
Sai Life Sciences Ltd, Pune, India
Full Time Jul-2008 To Dec-2013 5 years 5 months
Responsibilities
  • Managing Entire analytical laboratory related activities. People management, Financial and Administrative Management.
    DMPK, Pre-clinical drug discovery research, Bioanalytical, in-vitro assay, Pharmacokinetics.
Achievements
  • Best Team Award in FY-2012-2013.
    Best Performer award-2012
Group Leader-Bioanalytical Lab
Full Time Apr-2007 To Jun-2008 1 year 2 months
Responsibilities
  • Managing a team of 10-12 scientists for BA/BE analytical/bioanalytical related activities, GLP/Preclinical related activities.
Research Associate
Wockhardt Pharma, Mumbai, India
Full Time May-2005 To Apr-2007 1 year 11 months
Responsibilities
  • Managing a team of 4 people. Handled LC-MS/MS, HPLC, UPLC, ELISA, Spectromax etc.
Achievements
  • Best Performer Award-2006
Research Associate
Lambda Therapeutic Research Pvt Ltd; Ahmedabad, India
Full Time Aug-2001 To Jul-2003 1 year 11 months
Responsibilities
  • Handling Clinical Trails related activities, Protocol writing, Execution of Clinical Trails, DCGI, US-FDA audit
» 1 Project
Education
Doctor of Philosophy, Pharmacy
Jawaharlal Nehru Technological UniversityJawaharlal Nehru Technological University
2009-2014
Master of Pharmacy, Pharmaceutics
The Maharaja Sayajirao University Of BarodaMaharaja Sayajirao University of Baroda
2003-2005 Score68%
Bachelor of Pharmacy, Pharmacy
Amrutvahini Institute of Management and Business AdministrationUniversity of Pune
1998-2001 Score79%
2nd Topper in the University
Blogs & Portfolio
Ph.D with 13+ years of experience in Analytical, Bioanalytical and Clinical Research
Ph.D with 13+ years of experience in Analytical, Bioanalytical and Clinical Research
Portfolio
Ph.D with 13+ years of experience in Analytical, Bi...
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Sudipta Basu 21 Apr, 2015 25 view 0 Comments
Ph.D with 13 years of experience in Analytical and Bioanalytical Research
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Profile Snapshot
Sudipta is based out of Singapore & has studied Pharmacy, Ph.D-Doctor of Philosophy from Year 2009-2014 in JNTU-Jawaharlal Nehru Technological University, Jawaharlal Nehru Technological University.
Sudipta Basu is Skilled in Pharmacist, Biomedical Scientist, Analytical Chemistry and other talents.