FRD Complex Injectables

1. Formulation & Process Development

• Lead development of complex injectable formulations for regulated & semi regulated market:
  • Liposomal injections
  • Depot/long-acting injectables
  • Microspheres and nanoparticles
  • Peptide/protein injectables
  • Emulsions suspensions solutions lyophilized products
• Conduct pre-formulation and compatibility studies.
• Develop robust and scalable manufacturing processes suitable for commercial scale.
• Optimize critical process parameters (CPPs) and critical quality attributes (CQAs).

2. Documentation & Regulatory Compliance

• Prepare and review technical documents:
  • PDRs BMRs BPRs stability protocols
  • Product development reports
  • QbD documentation and risk assessments (FMEA DoE)
• Support preparation of ICH-compliant dossiers including Module 3 (CMC).
• Provide responses to regulatory queries for USFDA EMA MHRA TGA Health Canada and semi-regulated markets.

3. Project Management

• Lead and execute multiple formulation development projects simultaneously.
• Prepare project timelines milestones and risk mitigation plans.
• Coordinate with cross-functional teams: Analytical R&D Packaging RA QA IPM Supply Chain and Manufacturing.

4. Technology Transfer & Scale-Up

• Lead tech transfer to pilot/commercial manufacturing facilities.
• Oversee scale-up batches exhibit batches and validation batches.
• Troubleshoot formulation and process issues during development and scale-up.

5. Stability & Quality Evaluation

• Monitor stability studies as per ICH guidelines.
• Analyze stability trends investigate out-of-trend/out-of-spec results.
• Ensure compliance with Good Laboratory Practices (GLP) and cGMP.

6. Team Leadership

• Lead and mentor formulation scientists and junior researchers.
• Ensure training on new technologies QbD approaches and regulatory expectations.
• Build a culture of innovation and continuous improvement.