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Senior Executive, R&D- Formulation & Development

Senior Executive, R&D- Formulation & Development

ConfidentialPalghar, India
6 days ago
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, 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
  • Skills Required

    pellets , Formulation Development, Scientific Writing

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    Development Executive • Palghar, India

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