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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

Skills


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

Description


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 KEY RESPONSIBILITIES:

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

WHAT YOU’LL BRING TO THE ROLE:

• 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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