Senior Research Associate

3 days ago

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

Job Description:

Formulation Development candidate - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements.

  • Formulation Development:
  • Design and develop OSD formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products.
  • Perform pre-formulation studies, including solubility, stability, and compatibility evaluations.
  • Technology Integration:
  • Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets.
  • Optimize drug release profiles to enhance therapeutic efficacy and patient compliance.
  • Process Development:
  • Develop scalable and robust manufacturing processes for oral solid dosage forms.
  • Perform critical parameter optimization for processes like granulation, blending, compression, and coating.
  • Analytical and Stability Studies:
  • Collaborate with the analytical team to develop and validate testing methods for NDDS products.
  • Conduct stability studies in compliance with ICH guidelines.
  • Regulatory Compliance and Documentation:
  • Prepare technical reports, protocols, and batch manufacturing records.
  • Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development.
  • Technology Transfer:
  • Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing.
  • Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer.
  • Innovation and Research:
  • Stay updated with emerging trends in NDDS and oral solid dosage technologies.
  • Contribute to patent applications and publications to support organizational innovation initiatives.

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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