Senior Executive, R&D- Formulation & Development

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