About this role
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
Other facts
About Amneal India
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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What you'll do
- The role involves participating in project planning, monitoring R&D processes, and preparing reports. Additionally, it includes troubleshooting issues in coordination with plant and QA teams and ensuring compliance with regulatory requirements.
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