Hetal Bhatt Email & Phone Number

Interested to pursue research and development in vibrant laboratory environment. Knowledge of cGMP, GLP, ICH guidelines. Extensive hands on 21 years of analytical experience supporting fermentation, chemical manufacturing and biosimilar programs. Demonstrated leadership capabilities, organization, flexibility, and ability to operate in fast paced environment. Strong problem solving, creativity, and innovative skills applied for timely delivery. Proficient in standard computer software programs MS office Word, Excel, PowerPoint, Data acquisition Waters Empower software, and sample tracking systems like BPCS, ThermoLIMS. Lotus notes and Outlook e-mail software knowledge.Provide analytical support for biosimilar programs across early (pre-IND) and late (post-approval) phases of development. Execute analytical testing understand USP/BP/EP/IP requirements, interpret data and report final results in accordance with company standard operating procedures, cGMP and FDA guidelines. Release product, assist in peer review of data, write investigation, and prepare impurity profile reports. Provide support with validation testing needed for manufacturing, process support and MS&T group, along with routine quality control production demands. Good multitasking ability, work well as team player, initiative, and strong work habits. Well versed in instruments used in laboratory. Supported regulatory submissions including INDs and BLAs by compiling analytical data and authoring CTD stability sections.

Listed skills include Glp, Pharmaceutical Industry, Hplc, Analytical Chemistry, and 26 others.