Senior Executive, R&D- Formulation & Development

Job Summary

Senior Formulation & Development (F&D) Chemist

extensive hands-on exposure in the development of solid oral dosage forms

tablets and pellets

strong command over the preparation of Product Development Reports (PDRs)

Key Responsibilities

Formulation Development (Tablets & Pellets Focus):

• Develop robust and scalable formulations for immediate-release (IR), modified-release (MR), and delayed-release (DR) tablets as well as multi-particulate pellet formulations (coated or uncoated).
• Conduct pre-formulation studies, API characterization, excipient screening, and compatibility studies.
• Design and execute lab-scale, exhibit, and validation batches of tablets and pellets using QbD principles.
• Optimize critical formulation and process parameters for wet granulation, dry granulation, direct compression, extrusion–spheronization, layering, and pellet coating processes.
• Conduct process optimization and scale-up in coordination with manufacturing or pilot plant teams.
  

PDR Preparation & Documentation

• Independently prepare comprehensive and compliant Product Development Reports (PDRs), including:
• Justification for formulation approach and component selection
• Process design, optimization, and scalability strategy
• Risk assessment (FMEA) and control strategy
• Compatibility, stability, and in-process data interpretation
• Troubleshooting and change justifications (if applicable)
• Prepare supporting documentation such as MFR, FPSs.
• Ensure all documentation complies with ICH, USFDA, EU, and other applicable regulatory guidelines.
  

Regulatory & Quality Compliance

• Ensure all development and documentation activities are conducted in accordance with cGMP, GLP, and global regulatory expectations.
• Collaborate with QA and Regulatory Affairs during internal and external audits, as well as during regulatory filings.
• Contribute to dossier preparation by providing required CMC data and responding to technical queries.
  

Cross-Functional Collaboration

• Work closely with Analytical R&D, Packaging, QA, Regulatory, and Manufacturing departments to ensure project alignment and successful execution.
• Support technology transfer to commercial production teams with detailed technical input and documentation.
  

Team Leadership & Mentoring

• Guide junior scientists and trainees in conducting formulation trials, data analysis, and documentation practices.
• Train team members on best practices for tablets and pellets formulation and PDR preparation.
  

Qualifications & Experience

• Education: M.Pharm (Pharmaceutics) or B.Pharm
• Experience: 5–8 years in pharmaceutical F&D, with specific hands-on experience in tablets and pellets formulation
• Must-Have Skills:
• Deep understanding of granulation techniques, compression, coating, and pelletization processes
• Strong expertise in scientific writing and PDR preparation
• Experience in formulation development for regulated markets (e.g. EU, ROW, Russia, Chille and other regulated Market)
• Preferred: Exposure to QbD and regulatory filing