Ajit Sahasrabuddhe

Biography

Executive Officer Company Name Serum Institute of India Limited Dates Employed Sep 2015 – Present Employment Duration 2 yrs 1 mo Location Pune Quality Control Officer Company Name Serum Institute of India Limited Dates Employed Aug 2010 – Aug 2015 Employment Duration 5 yrs 1 mo Location Pune Area, India Microbiology Quality control: - Sterility assessment of liquid and lyophilized vaccines. -Microbial limit testing of water and raw material -Identification of contaminants, pathogens by gene sequencing (Microseq) -Standard culutures and vaccine strain characterization. -RT-PCR based detection of Mycoplasma contamination in Cell lines / in-process samples/bovine originated samples used for cell line based prodcuts eg. viral vaccines, master and working seed, bovine originated raw material, etc. -Bioburden analysis of in-process vaccine samples. - Media preparation and growth promotion testing. -Conducted periodic pathogen testing program of Laboratory animals(Mice, G.pig, Rats, Rabbits) -Environmental monitoring (viable and non-viable) Recombinant Hepatitis-B vaccine In process Quality control: -Culture Purity and viability testing. -vaccine strain specific enzyme assay. -Method development and validation of culture independent purity and identification testing by molecular methods. -Trending and data analysis. -Preparation of Standard Operating Procedures (SOP) -Preparation of analytical method validation protocol and report.

Research Interest

Pharmaceutical company