NDDS Injectable Formulation

2 days ago

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

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: Formulation R&D NDDS Injectable

Experience: 1 to 5 Years

Qualification: M. Pharm / Ph.D. (Pharmaceutics or Pharmaceutical Technology)

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