Roles and Responsibilities
Responsible for AMD, MV, TT / AMT/ Characterization/ Purification works, and timely closure of investigation reports, to deliver specific assigned tasks with High QUOTIF.
- Handling of 12-16 team of scientists to cater the structural characterization of the molecules.
- Responsible for Isolation and purification works including techniques like Prep LC and SFC etc.
- To develop the scalable preparative purification methodology and implement at scale.
- Responsible all structural characterization works including techniques like LC-MS/MS, GC-MS/MS, DSC, TGA, DVS, NMR etc.
- Preparation of Structure characterization reports for API and CMC projects based on requirement/project scope for Intermediates, APIs and unknown Impurities.
- Review NMR, Mass, DSC, TGA, PXRD, DVS, PSD etc, interpretation and conclusion.
- LC-MS, GC-MS analysis support to all Units QCs for dispatches.
- Development of quantification GTIs and Nitrosamines methods by LC-MS/MS, GC-HS-MS/MS and validation.
- To direct and guide the team for characterization and impurity profile document preparation for the API, intermediates, and impurities.
- To direct and guide the team to study the Solid-state chemistry, structure, and properties of solid phase materials for particle size engineering and crystallization.
- Following Good documentation and Good Laboratory practices in the work area.
- Ensuring Instrument calibrations and maintenance activity as per the schedule.
- Co-ordination with cross functional departments.
- Participates and contributes to technical brainstorming and Training and Development.
Desired Candidate Profile
Ph.D. with 14-16 Years experience or M.Sc. with 16-18 years’ experience