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Job Description

Job Description: AGM NDDS (Parenteral Formulation)

Position: Assistant General Manager NDDS (Parenteral)

Function: Research & Development

Experience: 1218 Years

Qualification: M.Pharm / PhD (Pharmaceutics or related discipline)

*Candidates preferably from reputed organizations with extensive research experience in the NDDS domain (FR&D) Preferably parenteral formulations.

Key Responsibilities

  • Lead NDDS parenteral formulation development including liposomes, microspheres, nanoparticles, longacting injectables, suspensions, and emulsions
  • Drive QbDbased product development, scaleup, and technology transfer to manufacturing
  • Oversee process optimization, robustness studies, and lifecycle management
  • Ensure compliance with global regulatory requirements (USFDA, EMA, ICH)
  • Lead and mentor formulation and process development teams
  • Collaborate with analytical, regulatory, QA, and manufacturing functions
  • Support ANDA / 505(b)(2) / complex injectable submissions and regulatory responses
  • Evaluate new technologies, platforms, and continuous improvement initiatives

Key Skills & Competencies

  • Strong expertise in parenteral NDDS technologies
  • Handson experience with scaleup, PPQ, and commercial manufacturing support
  • Indepth understanding of sterile processing, aseptic techniques, and cGMP
  • Regulatory submission experience and audit exposure
  • Strong leadership, stakeholder management, and strategic thinking

Desired Attributes

  • Proven peoplemanagement capability
  • Strong problemsolving and decisionmaking skills
  • Innovationdriven and qualityfocused mindset

More Info

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Job ID: 145100783