Formulation & Development (OSD) - Research Scientist

Job Summary:

Research Scientist

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.