NDDS Injectable Formulation
2 days ago
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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