- Should have knowledge regarding injectable drug products and should have experience in nano emulsions, suspensions, lyophilized based products, Peptides based products, non aqueous based products etc (should be experienced in atleast minimum two dosage forms).
- Daily planning, execution and monitoring of experiments for the team.
- Knowledge and experience in handling formulation equipments like Homogenizers, Microfluidizers, lyophilizer etc.
- Design and implementation of products based on Quality by design principles.
- Integration with cross functional teams (Analytical, QA and PMO) and ability to lead the project.
- Maintaining stability schedules, RLDs utilization, RMs and PPMs, components inventory management
- Preparation/ review of documents viz., stability protocols and reports, analytical, development studies reports, product development reports etc.
- Implementation/ monitoring of laboratory GLP and safety practices.
- Procurement and licensing requirements of the projects to be ensured
- Instrument maintenance, log books, LNBs review to be ensured
- Ability to take ownership of new formulation capability area and serve as the internal subject matter expert (SME); Eg., Lead the company’s ‘bag capability’ development initiative.
- Evaluate new technologies, materials, and equipment to expand the organization’s technical capabilities.
- Prepare due diligence (DD) documents, technical presentations, summary reports for both internal and external stakeholders.
- Conduct comprehensive literature reviews to identify relevant formulations trends, technologies, and competitive products.
- Participate in troubleshooting, risk assessment and strategy development for complex formulation challenges.
- Mentor junior scientists and ensure high scientific standards within the team.
