Sr. Executive - CPPK & Biopharmaceutics

View: 104

Update day: 01-04-2024

Location: Vadodara / Baroda Gujrat

Category: Pharmaceutical / Chemical / Biotech Health / Medical Care Pharmacist / Pharmaceutical representatives

Industry: Pharmaceutical & Life Sciences

Position: Bio/Pharma Informatics-Associate/Scientist

Job type: Full Time, Permanent

Salary: ₹ 3,50,000 - 7,50,000 P.A.

Experience: 3 - 5 years

Loading ...

Job content

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:

ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:

Loading ...

Click to apply for free candidate

Loading ...

Loading ...

Loading ...