Principal Scientist - IVIVC SME - Pharmaceutical

Hiring LGBT+ TALENT (LGBT+ stands for Lesbian, Gays, Bisexual, Transgender,Queer, Intersex)

Job Title: Principal Scientist - IVIVC SME

Location: Hyderabad

Company: Big Pharmaceutical Company

CTC: Best in the Industry

Job Description:

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.

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.

If you belong to the LGBT+ community then please send your CV to pamela@thepridecircle.com

NOTE: We are only considering applications from LGBT+ candidates (LGBT + stands for Lesbian, Gays, Bisexual, Transgender, Queer, Intersex)