Research Scientist

4 days ago

Ahmedabad, Gujarat, India Intas Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Job Description:

We are seeking a highly skilled and experienced professional for the role of Formulation Development OSD, focused on regulated markets including USFDA, MHRA, EMA, and other global regulatory agencies. The ideal candidate will have a proven track record in developing and optimizing solid oral dosage forms (tablets, capsules) for submission and commercial-scale manufacturing.

Key Responsibilities:

  • Lead and execute formulation development projects for oral solid dosage (OSD) forms targeted at regulated markets (US, EU, etc.).
  • Design and execute pre-formulation and formulation trials, optimization, and scale-up.
  • Develop robust formulations and manufacturing processes based on QbD principles.
  • Prepare and review technical documents including formulation development reports, technology transfer documents, and SOPs.
  • Work closely with analytical R&D, regulatory affairs, and production for seamless product development and filings.
  • Support exhibit batch manufacturing and tech transfer to commercial sites.
  • Ensure compliance with cGMP, GLP, and ICH guidelines during development activities.
  • Contribute to ANDA / Dossier preparation and review for regulatory submissions.

Key Requirements:

  • M. Pharm / M.S. in Pharmaceutics or related field.
  • 5 to 10 years of relevant experience in formulation development of OSD for USFDA or other regulated markets.
  • Strong knowledge of QbD, scale-up and technology transfer.
  • Experience in developing formulations for bioequivalence studies and regulatory submissions.
  • Familiarity with USFDA/EMEA regulatory guidelines and documentation.
  • Excellent problem-solving, documentation, and communication skills.

Preferred Skills:

  • Hands-on experience with granulation, compression, coating, and capsule filling equipment.
  • Ability to work cross-functionally in a fast-paced, deadline-driven environment.

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