Role Summary
To support formulation development trials for OSD products (pellets and tablets) — pre-formulation, formulation development, process validation, stability, and technology transfer — ensuring adherence to ICH guidelines and internal SOPs.
Key Responsibilities
1. Literature Survey & Pre-Formulation
- Conduct detailed literature reviews to support new product development initiatives.
- Evaluate reference products, patents, regulatory status, and formulation strategies.
- Perform physicochemical characterization of API and excipients.
- Assess compatibility, solubility, and stability as part of pre-formulation studies.
2. Formulation Development
- Design and develop robust formulations for pellet formulation using extrusion-spheronization, layering, and coating technologies (aqueous and non-aqueous).
- Develop tablet formulations via granulation, direct compression, and coating.
- Optimize process parameters through laboratory and pilot-scale equipment — extruder, spheronizers, FBD, Wurster coater.
3. Stability & Process Validation
- Conduct stability studies as per ICH guidelines and internal SOPs.
- Interpret results and recommend necessary formulation or process adjustments.
- Coordinate and execute process validation batches in the production department.
- Ensure compliance with GMP and validation protocols.
4. Technology Transfer & Troubleshooting
- Prepare and review technology transfer documentation (TTD), Formulation Development Reports (FDR), and protocols.
- Facilitate successful scale-up and handover of developed products to manufacturing.
- Provide technical support for commercialized products to resolve formulation or process issues.
Equipment to be Handled
- Extruder, Spheronizer, FBD, Wurster Coater
- RMG, Octagonal Blender
- Tablet Compression Machine, Tablet Coater
- Capsule Filling Machine, Tray Dryer
- Sieve shaker, Mill
Documentation & Compliance
- Follow ALCOA+ principles for data integrity.
- Adhere to cGMP, ICH guidelines, and Schedule M norms.
- Prepare and update Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly.
- Draft and review documents such as QAQN (Quality Assessment & Qualification Note), MFR (Master Formula Record), and FPS (Finished Product Specification).
- Participate in internal audits, regulatory inspections, and CAPA closure.
Qualification
B.Pharm / M.Pharm
Experience
1 – 3 years (OSD experience preferred).
Skills & Competencies
- Hands-on formulation development for OSD (tablets and pellets).
- Working knowledge of extrusion-spheronization, FBD, Wurster coating.
- Familiarity with ICH Q1A / Q8 guidelines.
- ALCOA+ rigour and data integrity awareness.
- Strong technical writing — PDF, MFR, FPS, TTD, FDR.
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