Senior Research Associate - Formulation Development OSD

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.