sarika savant

Perform QC testing of in process samples, lot release and stability samples in support of cGMP activities using the following analytical methods for different ADC & mAb molecules: SEC, CE-SDS , Free Drug, HIC, Titer Assay, iCIEF.

Perform GMP validations on clinical and commercial analytical methods testing large molecules. Reviewing validation data.

* Conducting research on a bacterial bioluminescence project that involves * Bacterial transformation & mini prep of plasmids * Restriction digest & PCR * Gel extraction & plasmid purification * Agarose gel electrophoresis

* Responsible for documenting protocols(HPLC and GC) for pre validation & validation studies of Active Pharmaceutical Ingredient (API) products as per ICH guidelines. * Coordinated with the Glenmark Regulatory team to answer queries, close deviations and formulate corrective and preventive actions to prevent recurrences.

* Solely responsible for all documentation activities (viz. Quality Manuals, Quality System Procedures, SOPs, etc) to get the lab accredited as per ISO 17025. * Served as the point of contact for all microbiological projects from project initiation to completion. * Coordinated with the team manager to allocate resources, document project schedules and progress. * Responsible for customer communication that included final reports submitted to the end users and resolving customer complaints. * Maintained well-organized laboratory notebooks in compliance with relevant procedures. * Helped in developing technical papers, posters, oral presentations, and web site material to be used for marketing purposes.

* Carried out Research for development of new Products & Culture Media. * Conducted bacterial staining, enumeration and identification of bacteria, media and buffer preparation. * Indenting & scheduling of products. * Calibration and Maintenance of various Stock Cultures and equipments * Performed air, water and environmental sampling & testing as per SOPs * Provided technical support to the sales and marketing team.