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.
