Formulation R&D Manager (Pellets Manufacturing)

Sri Ambikare Pharma; Hyderabad; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Sri Ambikare Pharma is seeking a Manager for Formulation Research & Development to lead pellet formulation programs, including development, optimization, technology transfer, and regulatory documentation for domestic and export markets. You will oversee experiments, ensure quality compliance, and mentor R&D scientists in Jadcharla, Telangana.

The role requires strong expertise in extrusion-spheronization, drug layering, coating technologies, and QbD, with substantial experience in pellet

Qualifications

• Qualification in pharmaceutics or related field with emphasis on pellet formulation development.
• Experience in regulated markets (US/EU) is preferred.
• Strong knowledge of extrusion-spheronization, coating and scale-up processes.

Responsibilities

• Lead formulation development of IR/SR/DR pellet formulations.
• Plan and execute lab and pilot-scale trials; troubleshoot issues.
• Coordinate scale-up and technology transfer to production.
• Prepare regulatory documentation and PDRs as per ICH guidelines.
• Mentor formulation scientists and manage project timelines.
• Ensure cGMP/GLP compliance and proper data integrity.

Skills

Extrusion-Spheronization

Drug Layering

Powder Layering

Pellet Manufacturing

QbD (Quality by Design)

cGMP/GLP

Wurster Coating

Enteric/Functional Coating

Education

M. Pharm (Pharmaceutics)

M.Sc in Pharmaceutical Science

B.Pharm

Job description

Designation: Manager – Formulation Research & Development 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

• 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.
• 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.
• 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.
• 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.
• 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 & MPRCTD/ACTD documents. Support for the BMR & BPR preparation. Support regulatory submissions for domestic and export markets.
• Team Management Lead and mentor formulation scientists and R&D executives. Allocate projects and monitor progress. Conduct performance reviews and technical training.
• 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.
• 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).

Qualification

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

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.