Assistant Manager- R&D Formulations & 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

• 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)

• 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.