NDDS Injectable Formulation & Development - Research Associate

Job Purpose:

To lead and execute formulation development of Novel Drug Delivery Systems (NDDS) in the injectable segment, including liposomes, microspheres, nanoparticles, depot injections, and other complex injectable formulations for regulated and semi-regulated markets.

Key Responsibilities:

• Design and develop NDDS injectable formulations such as liposomes, emulsions, microspheres, suspensions, nanoparticles, and depot systems.
  
• Conduct pre-formulation and formulation studies, compatibility studies, and risk assessments.
  
• Execute lab-scale and scale-up batches as per QbD principles and DoE designs.
  
• Evaluate and finalize suitable processes, components, and primary packaging materials.
  
• Ensure compliance with regulatory guidelines (USFDA, EMA, WHO, etc.) in documentation and development processes.
  
• Coordinate with analytical development teams for method development and stability studies.
  
• Prepare and review product development reports (PDRs), protocols, and technology transfer documents.
  
• Handle technology transfer to manufacturing sites and troubleshoot formulation-related issues.
  
• Work closely with cross-functional teams including Regulatory, QA, QC, Production, and Project Management.
  
• Stay updated with the latest technologies and scientific advancements in NDDS and injectables.
  

Skills and Competencies:

• In-depth knowledge of NDDS platforms for parenteral administration.
  
• Hands-on experience in sterile formulation development and aseptic techniques.
  
• Proficiency in QbD, DoE, and scale-up techniques.
  
• Familiarity with regulatory filing requirements (ANDA/NDA, Module 3).
  
• Strong documentation and data interpretation skills.
  
• Good communication and project management capabilities.

Department: