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 recent 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) 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.

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