Tanushree Chatterji Email & Phone Number

Durham, North Carolina, United States

Durham, North Carolina, United States

• I have developed and validated biomarker, immunogenicity, immune- and enzymatic assays for support of preclinical, clinical, and product release studies
• I Design and execute experiments efficiently
• I Write plans, reports and SOPs
• I am trained as a QC reviewer for bioanalytical projects and equipment logbooks
• I work with clients, scientists and analysts to assure successful execution of assay validation and sample analysis under non-GXP, spirit of GXP, and GXP
• I manage direct reports (1 Scientist and 2 Analysts)

Raleigh-Durham, North Carolina Area

• I worked closely with Bioanalytical Project Manager and analysts to assure successful execution of assay validation and sample analysis under GXP occurs within specified time frames
• I designed and executed experiments efficiently, conducted routine analyses, presented data, performed statistical analyses and quality control reviews, wrote reports, prepared SOPs, and traveled to meet with clients.
• I ran singleplex and multiplex immunoassays on MSD-ECL sector imagers, and immunoassays on Synergy 2 platform
• I analyzed and interpreted data and subsequently generated data summary tables to present to client
• I was a trainer on the new employee orientation team

• I lead multiple research and development projects: Involved in reviewing and evaluating experimental data
• I functioned as a liaison between the client and the technical team to facilitate a clear communication of project goals
• I am experienced in specification gathering, project planning, documentation and report writing
• I was involved in modifying, designing and optimizing protocols as per client needs for both manual and automated assays
• I have the ability to independently perform root cause analysis for method investigations
• I trained new staff on laboratory regulations and work protocols as well as overseeing the work of Junior Scientists and Lab Technicians

Houston, Texas Area

• I handled Cross functional responsibility spanning new Product Development, Manufacturing and Quality Assurance
• I was responsible for development, optimization, implementation and validation of ELISA for diagnostic purposes
• I was also responsible for adapting immunoassay protocols onto automated platforms - DS2, DSX, Keysmile, iFLASH & Union
• I was a Key member of manufacturing team overseeing – Reagent formulation and microtitration plate coating
• I was managing projects through idea conception, feasibility planning, status meetings and weekly reports
• I had to Create and maintain sample database for testing, future retrieval and tracking

Plano, Texas

• I handled all aspects of back office complaint handling for implantable spinal cord stimulators
• I had to document and maintain customer complaints records in accordance with 21 CFR 820.198
• I evaluated cases to assess merit of the complaint as per FDA regulations and formulate suitable action plan
• I reviewed Device History Records (DHR) to investigate any documented manufacturing defects or product non-conformances
• I performed periodic follow ups with the field representatives and/or customers to ensure timely complaint resolution
• I investigated complaints for potential reporting under FDA Medical Device Reporting regulations as per 21 CFR 803

Mumbai

I had hands on experience with calibration, troubleshooting and repair of control instruments

Executive Mba

Master'S Degree, Biomedical/Medical Engineering, 3.7 Gpa

Bachelor'S Degree, Instrumentation Engineering