Formulation & Development (OSD) - Research Scientist

7 days ago

Ahmedabad, Gujarat, India Intas Full time

Job Summary:

We are seeking a skilled and motivated Research Scientist to join our Formulation & Development (F&D) Oral Solid Dosage (OSD) team. The ideal candidate will be responsible for the design, development, and optimization of oral solid dosage forms (tablets, capsules, etc.) from concept to commercial scale. The role involves conducting pre-formulation studies, formulation trials, process optimization, and technology transfer to manufacturing sites while ensuring compliance with regulatory and quality standards.

Key Responsibilities:

  • Design and develop robust formulations for oral solid dosage (OSD) products, including tablets, capsules, and modified-release systems.
  • Conduct pre-formulation studies, excipient compatibility, and risk assessment.
  • Execute lab-scale, pilot-scale, and exhibit batch trials to optimize formulations and processes.
  • Prepare and review development reports, batch manufacturing records (BMR), and product development reports (PDR).
  • Coordinate technology transfer to manufacturing units and provide technical support during scale-up.
  • Support analytical teams in stability studies and interpretation of results.
  • Ensure cGMP, GLP, and regulatory compliance throughout the development process.
  • Collaborate cross-functionally with Analytical R&D, Regulatory Affairs, QA/QC, and Production teams.
  • Contribute to literature search, patent evaluation, and formulation strategy for new product development.
  • Document and maintain accurate experimental data in lab notebooks and electronic systems.

Required Skills & Competencies:

  • Strong understanding of formulation principles and process development for OSD forms.
  • Knowledge of pharmaceutical excipients, their functionality, and compatibility.
  • Hands-on experience with equipment such as RMG, FBD, blender, tablet compression, coating, and capsule filling machines.
  • Familiarity with QbD (Quality by Design), DoE (Design of Experiments), and scale-up principles.
  • Excellent documentation, analytical thinking, and problem-solving skills.
  • Ability to work in a regulated environment and meet project timelines.

Preferred Background:

  • Experience in generic formulation development for regulated markets (US/EU).
  • Exposure to ANDA/NDA filings, CTD documentation, and regulatory guidelines (USFDA, EMA).
  • Hands-on experience in troubleshooting and scale-up activities.

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