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.

- Solid 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 Health Care
📍 Palghar