Senior Executive, R&D- Formulation

2 days ago

Palghar India Pelltech Healthcare Full time

Job Description Job Summary We are looking for a highly competent and experienced Senior Formulation & Development (F&D) Chemist with extensive hands-on exposure in the development of solid oral dosage forms, specifically tablets and pellets. The candidate must possess in-depth knowledge of formulation strategies, process optimization, and regulatory documentation, with a strong command over the preparation of Product Development Reports (PDRs) in line with global regulatory expectations. 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, extrusionspheronization, 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: 58 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

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