Responsible for pre-formulation and formulation development, stability studies, scale-up, and GMP manufacturing of drug products based on the scope of projects. Knowledge expected in terms of complex generic or NCE products which include but are not limited to microspheres/ nanoemulsion/ liposomes.
- Project Execution and management (Knowledge expected in terms of complex generic or NCE products which include but not limited to microspheres/ nanoemulsion/ liposomes)
- Conduct literature search for research purposes
- Execute projects related to pre-formulation, formulation, and process development, scale-up, Technology transfer, and cGMP manufacturing of clinical supplies.
- Plan and execute stability studies and stability protocol preparation
- Ensure seamless execution of projects as per committed timelines.
- Ensure appropriate documentation for projects as per Syngene policy.
- Compilation and interpretation of results and report writing
- Manage laboratory notebook for all concerned projects. Compile and manage data and write protocols, and reports as required.
- Preparation and review of Master formula records, Batch manufacturing records, and Batch packaging records for the execution of GMP batches.
- Compliance and Adherence to all Syngene quality systems
- Compliance with Syngene EHS policies and systems
- Support for preparation of SOPs, EOPs, and IOPs.
- Support for client visits and audits.
Educational Qualification & Experience:
M Pharma with 3-6 years of experience