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Principal Scientist - IVIVC SME

 Hyderabad  10  1975

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Job Details

Company Top Pharmaceutical Giant
Position Principal Scientist - IVIVC SME
Required Experience 10-12 Years
CTC Best in the Industry
Location Hyderabad
Job Code 1975
Posted On 07 Sep 2021
Application Deadline 28 Feb 2022


Biopharmaceutics, WinNonlin, Gastroplus, Simcyp, SAS, JMP,


Job Description:

1886! We have more than 130 years of experience treating patients. It is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.


Your responsibilities include, but are not limited to:

• Assessment of relevance of in vitro dissolution/release characteristics on in vivo performance and selection of bio indicative method for product development

• IVIVC modeling in support of dissolution method development and setting up clinically relevant dissolution specification

• Bioequivalence risk assessment based on biopharmaceutics knowledge/IVIVC

• IVIVC assessment in support of formulation/Process change. Evaluation of the results of bio studies and suggesting on formulation strategies.

• Evaluation of RLD based on literature/experimental data and identify critical bioavailability attributes

• Preparation of BCS based Bio waivers report for regulatory submission

• Preparation of Bio waivers report based on modeling and simulation approach for regulatory submission

• Preparation of scientific report/justification in response to deficiency letter/post approval change

• Experienced in handling of novel dissolution (small volume dissolution, biphasic dissolution, precipitation study, USP-III/IV & permeation technology (Caco-2 cell permeability/IVPT study) for different dosage form (Complex oral solid/Injectable/Topical);

• Knowledge of statistical method to calculate dissolution similarity, population bioequivalence study, sample size and results of BE study.   

Minimum requirements


• Phd/M. Pharm in Pharmaceutics/Biopharmaceutics/Pharmacology with 10-12 years of experience

• Expert knowledge of Biopharmaceutics and modeling and simulation approach

• Hands on experience in WinNonlin, Gastroplus, Simcyp, SAS, JMP etc

• Experience in all dosage form like OSD, Injectable, topical.

• Work in close collaboration with multifunctional project team in designing project strategy, experimental invitro work.

• Should have strong analytical problem-solving skill, learning, adaptability and innovative experimental aptitude. Demonstrate good communication and presentation skills; and team connect & collaboration.

• Be up to date with scientific and industry trends, embrace and adopt industry innovations on modeling & technology and advanced analytics, Regulation and guidelines.

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