Senior Executive, R&D - Formulation & Development

Pelltech Healthcare; Palghar; On-site; INR 4,200,000 - 6,400,000; Full time

Job summary

Pelltech Healthcare is seeking an experienced F&D leader to drive formulation development for OSD tablets and pellets, including pre-formulation, design, process optimization, scale-up, and tech transfer. You will lead the F&D team, ensure compliance with ALCOA+ and data integrity, and support regulatory submissions.

The role requires strong expertise in wet/dry granulation, layering, coating, and robust cross-functional coordination with QA, RA, and Production.

Qualifications

• Must have strong leadership of F&D teams in regulated OSD (tablets/pellets).
• Expertise in wet/dry granulation, extrusion-spheronization, layering and coating.

Responsibilities

• Lead formulation development strategy for OSD products, including pre-formulation, design, scale-up and tech transfer.
• Oversee documentation, ALCOA+ data integrity, and compliance with cGMP/ICH Q8–Q10.
• Coordinate with QA, RA for timely submissions and defect closures during regulatory audits.
• Mentor junior staff and manage resource planning and development.
• Be the audit-facing lead during regulatory and customer audits.

Skills

F&D leadership

Formulation expertise

QbD/DoE experience

Technology transfer

Audit experience

ALCOA+ data integrity

Leadership skills

Education

M.Pharm (Pharmaceutics)

Job description

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.

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 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)

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.