Formulation R&D Manager (Pellets Manufacturing)

Designation: Manager – Formulation Research & Development (R&D)

Department: Research & Development

Location: OSD Manufacturing Plant ( Jadcharla, Telangana)

Reporting To: CEO / Plant head

Job Purpose

To lead and manage formulation development activities for pharmaceutical pellet-based dosage forms, including product development, technology transfer, process optimization, scale-up, validation support, regulatory documentation, and commercialization of pellet formulations in compliance with regulatory and quality standards.

Key Responsibilities

1. Product Development

• Develop immediate-release (IR ), sustained-release (SR ), delayed-release (DR ), and modified-release pellet formulations.
• Design formulation strategies for pellet manufacturing using extrusion-Spheronization, drug layering, powder layering, and coating technologies.
• Conduct pre-formulation studies and compatibility studies.
• Select suitable excipients and optimize formulations.
• Formula development as per the IISADP (Inactive Ingredients in Approved Drug Products) Percentage.
• Develop the innovative formulations.

2. Research & Development Activities

• Plan and execute formulation trials at laboratory and pilot scales.
• Troubleshoot formulation and process-related issues.
• Evaluate critical material attributes (CMAs) and critical process parameters (CPPs).
• Conduct risk assessments and Quality by Design (QbD) studies.

3. Technology Transfer

• Coordinate scale-up activities from laboratory to commercial manufacturing.
• Prepare technology transfer documents.
• Provide technical support during exhibit, validation, and commercial batches.
• Ensure smooth transfer of products to production.

4. Process Optimization

• Optimize palletization parameters such as:
• Binder concentration
• Extrusion speed
• Spheronization speed and time
• Drying parameters
• Coating parameters
• Improve product yield and reduce manufacturing costs.

5. Regulatory Documentation

• Prepare and review of Formulation SOP
• Prepare lab note books for Development batches
• Product development reports (PDR) as per the ICH Guidelines
• Technology transfer documents
• Risk assessment reports
• Prepare the MFR & MPR
• CTD/ACTD documents
• Support for the BMR & BPR preparation.
• Support regulatory submissions for domestic and export markets.

6. Team Management

• Lead and mentor formulation scientists and R&D executives.
• Allocate projects and monitor progress.
• Conduct performance reviews and technical training.

7. Compliance & Documentation

• Ensure compliance with cGMP, GLP, Data Integrity, and company SOPs.
• Maintain accurate R&D documentation and records.
• Participate in internal and external audits.

8. Technical Skills Required

• Good Knowledge about basic to advance Equipment operations and handling
• Pellet manufacturing technologies.
• Extrusion-Spheronization.
• Drug Layering & Powder Layering.
• Fluid Bed Processor (Wurster Coating).
• Enteric Coating and Functional Coating.
• Modified Release Formulation Development.
• Stability Studies report Analysis.
• Scale-Up and Technology Transfer.
• Regulatory Documentation (CTD/eCTD).

9. Qualification

• M. Pharm (Pharmaceutics) / M. Sc / B. Pharm
• Ph.D. (Preferred)

10. Experience

• 7 – 8 years of experience in pharmaceutical Pellets formulation R&D.
• Minimum 5 years of experience in pellet formulation development.
• Experience in regulated markets (USFDA, EU, MHRA, TGA, WHO-GMP) preferred.