Senior Executive, R&D - Formulation & Development

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

1. 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.
2. Formulation Strategy & Pre-Formulation Approve literature reviews, reference product evaluation, patent landscape, regulatory status, and formulation strategy for new 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).
3. 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.
4. 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.
5. Equipment Overseen Lab-scale and pilot-scale: Extruder, Spheronizer, Fluid Bed Dryer (FBD), Wurster Coater Rapid Mixer Granulator (RMG), Octagonal Blender Tablet Compression Machine, Tablet Coater Capsule Filling Machine, Tray Dryer Sieve shaker, Mill (Comil / Multimill) Documentation & Compliance Follow ALCOA+ principles for data integrity. Adhere to cGMP, ICH Q8 / Q9 / Q10, and Schedule M norms. Approve and maintain TTD, FDR, MFR, FPS, PDF, Product Logbooks and Instrument Logbooks. Participate in internal audits, regulatory inspections, and CAPA closure. Ensure calibration and preventive maintenance of all F&D equipment is up to date. Qualification M.Pharm (Pharmaceutics) Skills & Competencies Proven F&D leadership in regulated OSD pharma (tablets and pellets). Deep formulation expertise — wet / dry granulation, extrusion-spheronization, layering, coating. ICH Q8 / Q9 / Q10 (QbD) and DoE-based formulation experience. Strong technology-transfer and scale-up exposure. Excellent regulatory and customer audit-handling track record. ALCOA+ and data integrity rigour. Strategic, financial, and people leadership skills.