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