Amneal Pharma looking for Pharmacokinetic Modelling and Simulation Scientist

Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.

HIRING Pharmacokinetic Modelling and Simulation Scientist (NCE)

Post : Assistant Manager / Deputy Manager

Department : NCE | PB/PK Modelling

Location : Ahmedabad, Gujarat

Qualification : M.Pharm (Pharmacology)

Experience : 02-10 years

Required skills
• Develop, validate, and apply pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling' to support drug development programs.
• Conduct and present pharmacokinetic modelling and simulation (MAS) analysis to management and technical teams for project advancement.
• Predict human pharmacokinetics based on in-silico, in vitro, and in-vivo data, including dose scaling and profile prediction.
• Conduct I VIVE and IVI VC.
• Work closely with cross-functional teams including preclinical, clinical, and regulatory teams to guide decision- making and project direction.
• Utilize software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus Simcyp, PK-Sim, and other similar platforms for M&S.

• Develop and optimize mode Is for bioequivalence studies, sample size determination, and regulatory submissions.
• Support regulatory filings for New Chemical Entities (NCE), 505(b)(2), and generic products.
• Engage in all aspects of drug development, with a focus on predicting human pharmacokinetic and pharmacodynamic behaviour under different dosing regimens.
• Use advanced statistical approaches for bioequivalence analysis and large-scale data handling.
• Collaborate in the development and refinement of methodologies and approaches in PK modelling.
• Ensure clear communication of fin dings through presentations and written reports using Microsoft Excel, Word, and PowerPoint.