Job for Assistant Manager (Research Scientist) at Zydus Lifesciences

After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times. Our legacy of over 70 years in healthcare and being dedicated to life in all its dimensions is reaffirmed in our new mission, vision and purpose. Unifying ourselves under the Zydus name, Cadila Healthcare Ltd., is renamed as Zydus Lifesciences Ltd.

Inviting Candidates for PTC Moraiya, Ahmedabad

Post : Assistant Manager - Biopharmaceutics & Clinical Development (PTC Moraiya)

Experience : 2-5 Years
Qualification : M.Pharm (Pharmaceutics / Pharmacology)
Job Description :
1. Physiology Based Pharmacokinetic (PBPK) Modeling - Customization of Modeling & Simulation tools available primarily for new drug discovery to generic product development-Mechanistic IVIVC, Virtual bioequivalence
2. Identify alternative approaches for in vivo studies with scientific rationale, such as biowaiver and PBPK-based simulation. Provide recommendations to the team
and collaborate with other departments to implement these approaches
3. Analysis of dissolution data and predicting the in vivo performance of the dosage form: Mathematical IVIVC, modeling & simulation
4. Coordinate with external vendors for the troubleshooting and installation of software, as well as to get technical and logistic support
5. Complex injectables (Support in clinical development, immunogenicity study outsourcing and technical supervision)
6. Ensure timely delivery of project deliverables and resolve conflicts to facilitate the smooth execution of studies
7. Support the drafting of Controlled Correspondence and meeting documents for communication with regulatory agencies regarding dissolution, permeability, and
biowaiver, providing scientific justifications and responses to regulatory queries
8. Assist the formulation team and PK scientists with scientific inputs during the product development stage, as needed
9. Learning : Stay up-to-date on regulatory guidelines and updates; garnering the knowledge of emerging techniques and technologies related to Biopharmaceutics and PBPK modeling; learning the basics and applications of PBPK modeling using different softwares and modules to support development of all types of products.