Associate Scientist : Pharma Research OOD

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.