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Job Title: SR RESEARCH SCIENTIST
- Literature search related to the drug substance, create analytical profiles.
- Develop suitable analytical method for drug substance or drug product if not in Pharmacopoeia
- To carry out characterization of the API and conduct pre-formulation studies as planned by the formulator
- To conduct analysis of development samples as received from formulator and provide them with analytical report in the defined timeline.
- To conduct calibration of allotted equipment with proper documentation and maintain the equipment in good condition. To follow the SOP of usage and document in the log books.
- To conduct analysis of stability samples and prepare stability reports.
- To validate the method developed and prepare validation report
- Perform Lab to lab or Technology transfer of analytical method to the transferring site.
- Prepare all documents related to Tech Pack for commercial transfer of the method.
Maintain lab notebooks in proper condition and keep it updated at all times.
- To use PPE and follow safe practices in lab.
Critical Success Factors:
- Is able to conduct the literature search for every product and derive an analytical profile that helps in method development and analysis
- Think in a scientific manner to develop analytical method and demonstrate practically with timelines
- Is able to support Formulators for pre-formulation studies using various analytical techniques
Conducts the analysis on samples and provide the report within the timelines with no errors
- Understands the working of basic instruments such as Balances, pH meters, UV Spectrophotometer, HPLC, etc to do calibrations
- Understands validation, prepares validation protocol and conducts validation studies & report within timelines
- Is able to conduct the Stability studies within specified timeline and with accuracy. Indicate and report the change in the stability profiles
- Demonstrates the analytical method developed and transfers it without any issues to the receiving site
- Is able to plan and prioritize multiple project deadlines to meet product delivery goals
- Is able to write all documents based on the data from lab notebooks properly.
- Maintains lab notes for history and reference
- Understands the importance of PPE and practices the use of PPEs in the lab all the time (Personal Protective Equipment)