Deputy Manager - Pharmacokinetic Modelling
- Amneal Pharmaceuticals
- 3 to 7 Yrs
- Ahmedabad
- 25 days ago
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Job Description
- Job Description Develop, validate, and apply pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) 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 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 findings through presentations and written reports using Microsoft Excel, Word, and PowerPoint. Qualifications M. Pharm / Ph. D About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at 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 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: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.,
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Engineering Design / Construction
Functional Area: Not Specified
Role/Responsibilies: Deputy Manager - Pharmacokinetic Modelling and
Contact Details:
Company: Amneal PharmaceuticalsLocation(s): Ahmedabad
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Keyskills: IVIVC Regulatory submissions Statistical analysis Microsoft Excel Microsoft Word Microsoft PowerPoint
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Amneal Pharmaceuticals
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our nearly 6,000 colleagues are working to build one of the most dynamic pharmaceutical companies in our rapidly changing i...
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