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.
