Pharmacokinetic Modelling & Simulation Scientist | Amneal Hiring – Apply Now
Join Amneal Pharmaceuticals as a Deputy Manager – Pharmacokinetic Modelling & Simulation Scientist (NCE) in Ahmedabad, Gujarat, India. If you have expertise in PK/PD modeling, simulation, and drug development, this is an excellent opportunity to advance your career in the pharmaceutical industry.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company committed to innovation, quality, and accessibility in healthcare. With a strong presence in generics, specialty, and biosimilar medicines, Amneal focuses on developing high-quality, affordable treatments that improve patient outcomes worldwide.
Job Description of Pharmacokinetic Modelling & Simulation Scientist
Job Posting: Deputy Manager – Pharmacokinetic Modelling and Simulation Scientist | NCE
Location: Ahmedabad City, Gujarat, India
Responsibilities of Pharmacokinetic Modelling & Simulation Scientist
- Develop, validate, and apply pharmacokinetic and pharmacodynamic models (PopPK and PBPK modeling) to support drug development programs.
- Conduct and present pharmacokinetic modelling and simulation (M&S) 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 IVIVE and IVIVC.
- 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 models 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 behavior 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 modeling.
- Ensure clear communication of findings through presentations and written reports using Microsoft Excel, Word, and PowerPoint.
Qualifications for Pharmacokinetic Modelling & Simulation Scientist Role
M. Pharm / Ph. D
About the Team
Human Resources Team Overview:
- Executive Role: Specialists in all aspects of people management. High-level input at the strategic level into all key business decisions.
- Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
- Facilitator Role: Close partnership to support, advise, and extend the ability of all areas of the organization to meet their objectives through the implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health, and Wellbeing.
- Consultancy Role: Provide expert advice to the organization and its managers on any aspect of workforce management and employee relations and performance.
- Service Role: As a Pharmacokinetic Modelling & Simulation Scientist, ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation and changes in the characteristics of the labor market.
Keywords: Job Posting, Deputy Manager, Pharmacokinetic Modelling, Simulation Scientist, NCE, Ahmedabad, Gujarat, India, Amneal, Equal Opportunity Employer, Diversity and Inclusion
