Junior Executive, R&D-Formulation & Development

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.