Sushma Singh Email and Phone Number

Develop stability indicating methods, including the use of HPLC and GC cleanup techniques, solid phase extraction, immunoaffinity column cleanup, and GPCValidation, verification and transfer of methods according to GMP/ GLP, FDA/ICH guidelines and oversight of methods and studies at contract laboratoriesExperience with topical method development and validation.Experienced in Development and Validation of conventional and automated dissolution methodsExperienced with moisture determination using automated and conventional Karl FisherPerformed Technical Transfer international.Experienced in preparing COA for clinical release samplesRecertification of reference standard and reference materialExtensive experience in analysis of clinical release samples and stability samplesExtensive experience with LIMS data system and Trackwise system for investigation and change managementPerform stability studies according to GMP/GLP/ICH , maintaining stability chambers and Rees SystemExtensive experience in use of analytical instrumentation such as HPLC (Agilent 1100 series and Waters Alliance, Acquity), CE, GPC, Viscometer including soft wares such as Agilents Chemstation, Waters Millennium and Empower2 and 3, chromtech and Agilents Cerity) Metabolite isolation and identification using 14C tracers, oxidizers, scintillation counting, HPLC and TLCFamiliar with FDA, EPA, ICH,USP and EU guidelinesPreparation of CMC sections, protocols, methods, standard operating procedures, Certificate of Analysis and reports for regulatory submissionsExperienced in running Chloride Channel binding assays, preparing cultures and membranesExperienced in phlebotomy and analyzing blood for clinical chemistry, immunology, and hematologyExtensive experience in handling and analyzing blood, urine, plasma, animal tissues, plant tissues, soil, and waterQualification and validation of laboratory instruments, 21 CFR Part 11 compliance, IQ, OQ, & PQ