Narasa Raju Ale

Highly motivated team player with 15 years of experience in pharmaceutical analytical Research and Development supporting drug development at various stages such as  library, Medchem, Clinical and API and support  for DMF filings.

Expertise in separation science technologies such as HPLC, Chiral HPLC& GC, Preparative HPLC isolations, Gas chromatography, Multi-dimensional chromatography, capillary electrophoresis, ion chromatography and GPC.

Expertise in development and optimization of analytical methodologies (Related substances & assay by HPLC and GC) for APIs, raw materials, intermediates, in-process controls (IPC), NCSS targets and NCEs. And supported method validations and  transfers and  plant investigations (OOS/OOT)

Expertise in impurity profiling and characterization of unknown impurities in API’s, intermediates and starting materials by  LC-MS, GC-MS, FT-IR and NMR-1H, 13C and 2D-NMR techniques.

Technical support for development and validation of chiral HPLC/GC methods for determination of enantiomeric purity using different types of CSPs such as polysaccharide (coated and immobilized phases), cyclodextrin and protein based CSPs and derivatizations methodologies.

Supported various projects in analytical development related to peptide APIs,  fine chemicals, surfactants, pesticides and polymers (Polyester polyols, Polyurethanes dispertions, Polymethyl methacrylates and polypropylenes )

Trained on Agilent process GCs and Siemens Maxum-II process GCs and expertise in  parallel chromatographic techniques

Experience in handling multiple Clients/ CROs projects across different geographies in various analytical  programs to deliver the projects on time.

Experience in setting up of new analytical developmental laboratories in different organizations understanding the new regulatory requirements.