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:
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.
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.
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 PDR preparation, 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