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Senior Scientist, Biopharmaceutics Hyderabad

3.00 to 6.00 Years   Hyderabad   30 Oct, 2019
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Job Title:Senior Scientist, Biopharmaceutics Location: Hyderabad Exp: 3-6 Years Responsibilities:

  • Assessing the complexity of products in terms of achieving bioequivalence
  • Identifying critical material attributes (CMA) of the drug substance and excipients, critical formulation components (CFC) and critical process parameters (CPP) that are expected to affect bioavailability and bioequivalence
  • Identifying appropriate in-vitro characterizations tools and methodologies relevant to the in-vivo behaviour of the formulations leading to selection of appropriate formulation strategies and/or optimizing formulations to enhance success in bioequivalence studies.
  • Analyzing data of bioequivalence studies with an object to identify critical parameters (CMA, CFC, CPP) that led to success or failure and suggest corrective course if required.
  • Providing input to clinical pharmacology & pharmacokinetics (CPPK) team on critical aspects of the drug release that could be considered while designing bioequivalence studies.
  • Development of IVIVC/IVIVR when feasible
  • Performing modelling& simulations to predict in-vivo outcome based on in-vitro characteristics
  • Preparing biowaiver reports for submission to regulatory agencies
  • Addressing regulatory deficiencies related to dissolution and bioequivalence
Interested candidates kindly send your resume to naveenkumar@bvrpc.comSalary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, BiotechnologyRole Category: R&DRole: Research ScientistEmployment Type: Full Time, Permanent , Education:UG -B.Pharma - PharmacyPG - M.Pharma - Pharmacy

Keyskills :
researchvalidation documentationapi hplcmusic making clinical pharmacologycfc pharma

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