Vijay Murthy Email & Phone Number

Pittsburgh, Pa, Us

Greater Pittsburgh Area

Pittsburgh, Pa

Pittsburgh, Pa

Holly Springs, Nc

Braintree, Ma

Citra Labs, LLC, a Biomet Biologics company, develops and markets blood rejuvenation solution and citrate-based anticoagulants. My role was to contribute to the implementation of a new Production Clean Room Suite (PCRS) for manufacturing operations. Primary roles include cGMP microbiological testing, coordinating metrology program, purchasing and release of materials and validation. I organized the metrology program and developed business relationships with associated vendors. I managed the calibration of production equipment, WFI Distribution, WFI Still, and USP water systems. I also performed in-process testing for TOC/Conductivity, bioburden, pH, endotoxin (kinetic and gel-clot), and environmental monitoring for viable, non-viable, and surface testing. I assembled batch records for QA approval, commercial batch release, and regulatory compliance. I created and revised Standard Operating Procedures (SOPs) for in-process methods and initiated and investigated deviations and OOS’ per SOP using various root cause analysis methods. I created P.O's for purchasing and release incoming shipments from suppliers and worked in collaboration with production team members to sample, ship, and record batch tests for sterility, particulate, and assay testing.

Hopkinton, Ma

Lonza is a mid sized Biopharmaceutical company that provides contract manufacture of monoclonal antibodies (mAbs) and recombinant proteins from mammalian cell culture. Primary duties would include conducting Bioburden, Endotoxin (gel-clot), Environmental Monitoring testing in Class 100 (ISO 5), Class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean room environments. Sampled from WFI, USP, and clean steam ports using proper aseptic technique. Paperwork for deviations and site excursions. Collaborated with functional group to organize performance quality sampling. Organized laboratory with proper items, monitored inventory, and placed orders for new supplies.

Lowell, Ma

Examined patient specimens Earned university appraisal for a descriptive and comprehensive presentation about the genetic pathways and physiological activities. Processed samples for measurement in University studies, Particle Sizer, HPLC, MS