Vandana Kulkarni, MS

Vandana Kulkarni has a master’s degree in microbiology and has completed the Professional Development Program for Quality Assurance and Regulatory Affairs in Biopharmaceutical Industry.

Ms. Kulkarni is Laboratory Manager at Byramjee Jeejeebhoy Government Medical College Clinical Research Site (BJMC-CRS) in collaboration with Johns Hopkins University, Baltimore, USA, where she has worked since September of 2004. During the last 11 years, she has worked in the research laboratory providing lab support to NIH-funded ACTG and IMPAACT trials as well other studies.

She is responsible for the overall operations of the research laboratory and for supervision of laboratory staff comprising laboratory supervisors and technicians, and evaluates personnel competency and proficiency as well as waste management, vendor development for instrument purchase, and maintenance contracts. She also is responsible writing and revising all laboratory standard operating procedures (SOPs), for training staff in new methodologies as required, and for ensuring that laboratory and staff operate under Good Clinical Laboratory Practices. Additionally she conducts method/instrument validations, ensures that periodic EQA evaluations and methodology improvements are conducted to ensure that quality control and quality assessment programs are established and maintained, maintains the specimen repository and coordinates international shipping, lab documentations, and is responsible for annual audit to the Division of AIDS, NIAID, NIH. She is also responsible for procuring import and export permits for lab. Her prior experience includes quality control, microbiological testing, antibiotic and vitamin assays, and toxicity and sterility testing in the pharmaceutical industry. She has undergone GCLP, IATA and LDMS trainings.