Research Associate
lupin ltd
Work from Office
Full Time
Min. 5 yearsJob Description
Research Associate : Pharma Research OOD
Job Description
Formulation & Product Development
- Independently design and develop solid oral and/or ophthalmic formulations.
- Perform pre‑formulation studies including excipient compatibility, solubility enhancement, particle characterization, and stability assessment.
- Execute process development and optimization studies such as blending, granulation, compression, coating, sterilization, and filling.
- Support pilot and scale‑up batches and assist in technology transfer to manufacturing sites.
Process Understanding & Optimization
- Identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) using QbD principles.
- Perform risk assessments (ICH Q9) and support development of control strategies.
- Troubleshoot formulation and process‑related issues during development and scale‑up.
Analytical & Characterization Activities
- Plan, review, and interpret routine analytical testing including:
- Assay, content uniformity, dissolution
- pH, viscosity, osmolality (ophthalmic)
- Particle size distribution, hardness, friability
- Coordinate with Analytical R&D for method development and validation.
Documentation & Regulatory Support
- Prepare and review development reports, scale‑up and site‑transfer protocols, stability summaries, and risk‑assessment documents.
- Contribute to CTD Module 3 (3.2.P) documentation for ANDA / NDA / global submissions.
- Ensure compliance with ICH, USFDA, EMA, WHO, and internal quality systems.
Work Experience
M. Pharm (Pharmaceutics) with 5-7 years
Education
Competencies
Experience Level
Mid LevelJob role
Job requirements
About company
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