Deputy Manager - Pharmacokinetic Modelling and Simulation Scientist Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus, Simcyp, PK-Sim, and other similar platforms for M&S will be an essential part of your role. Furthermore, you will be expected to develop and optimize models for bioequivalence studies, sample size determination, and regulatory submissions. Supporting regulatory filings for New Chemical Entities (NCE), 505(b)(2), and generic products will also be within your responsibilities. Your focus will be on engaging in all aspects of drug development with an emphasis on predicting human pharmacokinetic and pharmacodynamic behavior under different dosing regimens. Using advanced statistical approaches for bioequivalence analysis and large-scale data handling, you will collaborate in the development and refinement of methodologies and approaches in PK modelling. It is crucial to ensure clear communication of findings through presentations and written reports using Microsoft Excel, Word, and PowerPoint. Qualifications: - M. Pharm / Ph. D Amneal is an equal opportunity employer and does not discriminate based on caste, religion, gender, disability, or any other legally protected status. The organization values diversity and inclusion in the workplace. The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative management of people for both current and future business needs. Their key roles include: - Executive Role: Specialists in all aspects of people management providing high-level input at a strategic level into all key business decisions. - Audit Role: Ensuring 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 highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. - Consultancy Role: Providing expert advice to the organization and its managers on any aspect of workforce management, employee relations, and performance. - Service Role: Ensuring the organization is fully aware of and equipped to deal with developments impacting employment matters, such as changes in legislation and characteristics of the labor market.,

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