Executive- R&D-Formulation & Development

Role Summary

To execute formulation development trials for OSD products (tablets and pellets) — pre-formulation studies, formulation design, lab-scale trials, and pilot-scale scale-up - strong command over the preparation of Product Development Reports (PDRs) — under the Senior Executive's guidance.

Key Responsibilities

1. Literature & 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 (solubility, particle size, hygroscopicity, polymorph).
• •Assess API-excipient compatibility, solubility, and stability as part of pre-formulation studies.

2. Formulation & Process Development

• •Design and develop robust formulations for tablets and pellets using extrusion-spheronization, layering, and coating (aqueous and non-aqueous).
• •Develop tablets via wet / dry granulation or direct compression as per product strategy.
• •Optimize process parameters through laboratory and pilot-scale equipment — extruder, spheronizers, FBD, Wurster coater, RMG.
• •Apply DoE / QbD principles to identify critical process parameters and critical material attributes.

3. Stability, Validation & Documentation

• •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.
• •Prepare and review technology transfer documents — TTD, FDR, protocols.
• •Facilitate successful scale-up and handover of developed products to manufacturing.

4. Troubleshooting

• •Provide technical support for commercialized products to resolve formulation or process issues.
• •Train Junior Executives and Trainees on formulation principles and equipment operation.

5.Equipment to be Handled

• •Extruder, Spheronizer, Fluid Bed Dryer (FBD), Wurster Coater
• •RMG, Octagonal Blender
• •Tablet Compression Machine, Tablet Coater
• •Capsule Filling Machine, Tray Dryer
• •Sieve shaker, Mill (Comil / Multimill)

6.Documentation & Compliance

• •Independently prepare comprehensive and compliant Product Development Reports (PDRs)
• •Prepare and update Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly
• •Follow ALCOA+ principles for data integrity.
• •Independently prepare comprehensive and compliant Product Development Reports (PDRs)
• •Adhere to cGMP, ICH Q8 / Q9 / Q10, and Schedule M norms.
• •Draft and review TTD, FDR, MFR, and FPS.
• •Participate in internal audits, regulatory inspections, and CAPA closure.

Qualification

B.Pharm / M.Pharm

Experience

3 – 5 years; able to run an area or shift independently (OSD experience preferred).

Skills & Competencies

• •Strong hands-on formulation development for OSD (tablets and pellets).
• •Working knowledge of extrusion-spheronization, FBD, Wurster coating, granulation, compression, coating.
• •QbD and DoE methodology per ICH Q8.
• •ALCOA+ rigour and data integrity awareness.
• •Technology transfer and scale-up support.
• •Strong technical writing — TTD, FDR, MFR, FPS.