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 (Senior Executives, 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 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).
- 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 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)
Experience
8 – 12 years; multi-section / department-coordination level (OSD experience preferred).
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.
