R&D Job at Amneal | Pharmaceutical Sciences Graduates Apply Now
Amneal is seeking a dynamic Officer to Executive – R&D for its facility in Dahej SIR, Gujarat. This R&D Job is central to the organization’s API Process Development and Technology Transfer initiatives, requiring a technical expert to manage the transition from lab-scale experiments to full-scale plant validation. Ideal candidates will possess an M.Sc in Organic Chemistry or a Ph.D. and have 3–7 years of experience in troubleshooting, yield optimization, and regulatory documentation.
- Job Title: Officer to Executive – R&D
- Location: Dahej SIR, Gujarat, India
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 the plant and QA teams.
- Ensure timely submission of R&D and validation samples to the 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 the 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.
Education
- Ph.D – Chemistry / Pharmaceutical Sciences is preferred for the Amneal Job
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
