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Sr. Executive - CPPK & Biopharmaceutics

3.00 to 5.00 Years   Vadodara   02 May, 2021
Gowrie Healthcare Pvt Ltd No3, BPEstate,OppSitaram SuperMarket, Chhani
Job LocationVadodara
EducationNot Mentioned
SalaryRs 3.5 - 8 Lakh/Yr
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

PRIMARY RESPONSIBILITIES:

  • Conducting extensive literature search related to Pharmacokinetic parameters, BA/BE studies.
  • Evaluation of development projects with respect to physicochemical properties and pharmacokinetic properties and its impact on BA/BE studies.
  • Preparation of design strategy and decision tree regarding dissolution media selection note for formulation development.
  • Identification of bio-relevant in-vitro dissolution media and test conditions based on physicochemical characteristics and pharmacokinetics of the drug molecule and supporting the formulation development team in developing bioequivalent formulations.
  • Conducting In-vitro In-vivo correlations/relations (IVIVC/IVIVR).
  • Development of sound scientific strategies to investigate any BA/BE failures and provide inputs to the respective cross functional teams.
  • Preparation, review and finalization of Pilot and Pivotal bio study protocols.
  • Review of Pilot and Pivotal bio study reports.
  • Perform statistical calculations on the in-vivo data (BE data) and extrapolation of data to find suitable number of subjects required for BE studies and designing BE studies accordingly.
  • Coordinate with the CROs for conducting pilot/Pivotal biostudies and tracking the studies progress and outcome.
SECONDARY RESPONSIBILITIES:
  • Preparation of SOPs related CPPK/Biopharmaceutics team.
ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:
  • Sound knowledge on pharmacokinetics ADME.
  • Deep understanding on In-vitro in-vivo correlations.
  • Knowledge on Bio-relevant dissolution, FaSIF, SIF, SGF, FeSIF media etc.
  • Knowledge on BA/BE/PKPD studies.
,

Keyskills :
conductingdesign strategymedia selectionfinalizationstrategic designcalculationssifpharmacokineticsdevelopment projectsformulationsearchconcept generationhypershotsounddissolutionformulation developmentdesignliteraturestrategypivotal

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