Senior Executive, R&D- Formulation & Development

Location: Virār

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