Role Summary

To lead F&D; formulation development for OSD products (tablets and pellets) — driving pre-formulation, formulation design, process optimization, scale-up, technology transfer and stability — and to be the F&D; lead during regulatory submissions.

Key Responsibilities

Section Leadership
Lead the formulation team (Executives, Junior Executives, Trainees) across pre-formulation, formulation design, process optimization, lab-scale and pilot-scale trials.
Plan F&D; portfolio — prioritize new products, ANDA / DMF deficiencies, and post-approval improvements.
Mentor and develop second-line leadership; manage manpower planning and engagement.
Formulation Strategy & Pre-Formulation
Approve literature reviews, reference product evaluation, patent landscape, regulatory status, and formulation strategy for current products.
Approve pre-formulation study reports — physicochemical characterization of API and excipients, compatibility studies, solubility, stability.
Approve formulation development strategy for tablets and pellets — wet granulation, dry granulation, direct compression,



extrusion-spheronization, layering, and coating (aqueous and non-aqueous).
Tech Transfer & Compliance
Approve technology transfer documents — TTD, FDR, MFR, FPS, PDF.
Approve Product Development Report (PDR) for new and existing OSD products before submission and audit.
Be the audit-facing person for F&D; during regulatory and customer audits.
Approve stability protocols and reports per ICH Q1A(R2), Q1B, Q1E.
Drive ALCOA+ and data integrity compliance across F&D.;
Cross-Functional Coordination
Coordinate with ADL on analytical method development, validation, and stability analysis.
Coordinate with Production for scale-up, process validation, and routine commercial troubleshooting.
Coordinate with QA, RA on submission timelines, deficiency response, and post-approval changes.
Equipment Overseen
Lab-scale and pilot-scale: Extruder, Spheronizer, Fluid Bed Dryer (FBD), Wurster Coater
Rapid Mixer Gr

📌 Senior Executive, R&D (Palghar)
🏢 Pelltech Healthcare
📍 Palghar