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