vijay kumar

• Authoring, reviewing and approving test methods, protocols and technical reports
• Chromatographic Analyses including Process Related Residuals
• Follow, understand and comply with SOP’s and policies on cGMP’s and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas
• Lead the analytical aspects of a project while working with other functional areas to advance projects through the pipeline
• Serve as a liaison between functional groups and external customers for analytical development, transfer, troubleshooting and improvement efforts
• Manage analytical projects. Establish schedules, define dependencies and project plans and direct activities of other scientists and non-scientists as well as provide training and development for others
• Develop, validate, transfer and troubleshoot API analytical methods, including raw materials, in-process and API testing

• Assist in conducting method validation experiments
• Document all work processes according to GMP standards
• Analytical method development and qualification
• Writing SOPs and technical reports
• Maintaining equipment calibration and preventative maintenance

• Periodical calibration of instruments like HPLC, UPLC and Analytical balances etc.
• Routine testing for PR&D, in-process and stability testing.
• Provide support in method development and validation testing.
• Provide support in project management with contract manufacturing and testing facilities.
• Ensure data integrity, Conduct data collection, interpretation and ensure proper documentation of experimental data. Maintain laboratory notebooks.
• Complete assignments requiring an expert level knowledge of techniques and practices related to the analytical area.
• In collaboration with the synthesis scientist, design and perform analytical laboratory research experiments.
• Excellent skills in collecting data and accurately maintaining laboratory notebooks required.

• Related substances method validation, Assay method validation, genotoxic impurity method validation at TTC level.
• Preparation and review of Analytical Method Validation protocols (Pharmaceutical products and related substances) and reports.
• Forced Degradation study of final API molecules.
• Pharmacopoeial Evaluation of various product
• Periodical calibration of instruments like HPLC, Analytical balances etc.

• Method Development in Preparative HPLC, Isolation and Purification of Various type of Impurity
• Analysis of finished product Raw materials, In-process sample, Intermediates and API, (Reaction Monitoring, Qualititative, Quantitative) as per USP, EP and In-house specification on HPLC.
• Responsible for generation and updation of specifications, procedures and SOPs for API as well as finished products.

Post graduate degree in Pharmaceutical chemistry