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Amneal Pharmaceuticals
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Officer To Executive - R&D

Officer To Executive - R&D

Amneal Pharmaceuticals

3 - 7 years

3 - 4 Lacs

Dahej

Posted:8 hours ago| Platform:

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Skills Required

Organic chemistry Root cause analysis Analytical Pharma R&D Executive Process development Project planning GLP data integrity Continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

Essential Functions:

Participate in project planning and distribution of R&D tasks and responsibilities.
Monitor and evaluate process verification schedules, plant verification batches, and prepare corresponding reports. Compare yield and quality trends of R&D verification batches and plant validation batches. Prepare, review, and interpret characterization reports for working standards, key starting materials (KSMs), and related substances. Prepare and verify documentation related to R&D process verification and validation batches. Support in plant-scale investigations and troubleshoot issues in coordination with plant and QA teams. Ensure timely submission of R&D and validation samples to Analytical Development Lab (ADL) and follow up for results. Coordinate sample dispatches (RM/intermediates/API) to the Ahmedabad API R&D division for further testing. Communicate with the Raks Ahmedabad API R&D team for technical discussions, project updates, and experimental outcomes. Assist in documentation related to Consent for Establishment (CFE), Drug Licenses, and regulatory submissions. Review of stability study data generated for development and validation batches. Perform and review routine verification and calibration of laboratory instruments used in process development. Review and approve documents related to process development (PD) and validation activities. Train junior staff or subordinates on lab safety, process understanding, and documentation practices.

Additional Responsibilities:

Ensure compliance with data integrity, GLP, and cGMP practices in R&D operations.
Participate in technology transfer from R&D to the production plant and ensure smooth scale-up. Support generation of documents for regulatory filings, including development reports and protocols. Assist in root cause analysis and CAPA implementation related to process deviations. Maintain records of sample tracking, logbooks, and development experiments in compliance with QA requirements. Participate in internal and external audits relevant to R&D activities. Ensure upkeep and maintenance of R&D equipment and request calibration/servicing as per schedule. Drive continuous improvement and cost optimization in process development. Collaborate with QA/QC, Production, and RA teams for project coordination and compliance.

Qualifications

:-

Education:

Master Degree, M. Sc - Organic Chemistry - Preferred
Ph.D - Chemistry / Pharmaceutical Sciences - Preferred

Experience:

3 to 7 years of experience in API R&D/process development

Skills:

Process Development & Scale-Up - Advanced
Plant Validation & Technology Transfer - Intermediate to Advanced Analytical Result Interpretation - Intermediate Process Troubleshooting - Intermediate Documentation Review (PD, Validation, Stability) - Advanced Communication with Cross-Functional & R&D Teams - Intermediate to Advanced Knowledge of Regulatory Documents (CFE, Drug License) - Intermediate cGMP, GLP & Data Integrity Principles - Advanced Instrument Calibration & Review - Intermediate Training & Mentorship - Intermediate

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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Officer To Executive - R&D