Shankar Sankaran Email & Phone Number

Folsom, Ca, Us

Folsom, California, United States

Oversight of Analytical Development and Validation teams, Reference Standard Teams, Stability Teams, and Release Testing teams (totaling 50+ chemists) supporting internal manufacturing and testing activities at US sites as well as external contract testing for third parties. Leverage expertise in various instrumentation and analytical chemistry to provide technical and scheduling oversight for projects. Direct operations of laboratory sites and incorporation of new laboratory techniques. Responsible for setting analytical CMC strategy, drafting, reviewing and updating analytical sections for various ANDAs and DMFs and providing guidance for phase appropriate development and validation. Responsible for writing technical proposals to bring on new analytical projects. Responsible for business operations including budget management, revenue forecasts and reporting and development of business plans.

Oversight of Analytical Development and Validation teams, Reference Standard Teams, Stability Teams, and Release Testing teams (totaling 50+ chemists) supporting internal manufacturing and testing activities at US sites as well as external contract testing for third parties. Leverage expertise in various instrumentation and analytical chemistry to provide technical and scheduling oversight for projects. Direct operations of laboratory sites and incorporation of new laboratory techniques. Responsible for drafting, reviewing and updating analytical sections for various ANDAs and DMFs and providing guidance for phase appropriate development and validation. Responsible for writing technical proposals to bring on new analytical projects. Responsible for business operations including budget management, revenue forecasts and reporting and development of business plans.

Rancho Cordova, California

Responsible for overseeing teams of chemists in the Analytical Method Development department. Leverage expertise in various instrumentation and analytical chemistry to provide technical and scheduling oversight for projects. Direct operations of laboratory sites and incorporation of new laboratory techniques. Responsible for writing technical proposals to bring on new analytical projects. Responsible for drafting, reviewing and updating analytical sections for various ANDAs and DMFs.

Responsible for overseeing a team of chemists in the Analytical Method Development department. Leverage expertise in various instrumentation and analytical chemistry to coordinate and manage projects. Oversee start up and manage operations of a new laboratory site and incorporation of new laboratory techniques. Responsible for writing technical proposals to bring on new analytical projects. Responsible for drafting, reviewing and updating analytical sections for various ANDAs and DMFs.

Development and Validations of analytical methods for use in testing and release of APIs including but not limited to HPLC, UHPLC, GC, FTIR, NMR, DSC, TGA, GC-MS, LC-MS and ICP-OES. Provide technical input for analytical CMC sections for a variety of drug substance filings.

-Testing and release of in-process samples for manufacture of APIs-Training new employees in analytical techniques including HPLC, UHPLC, GC, KF, NMR and FTIR

Testing and release of in-process samples for manufacture of APIs