Vincent Prakash Email & Phone Number

Fremont, Ca

San Carlos, Ca

• Supported the Quality Control group in testing of Antibody Intermediate for Release, in-process and Stability by HPLC, UPLC, icIEF, UV-Vis to determine the Identity, Purity and Quantitation.• Performed Total protein quantitation using the Thermo Scientific Coomassie Plus (Bradford) Kit• Performed TOC and Conductivity of water samples using Sievers M9 Lab TOC Analyzer• Reviewed analytical data for the QC group

Hayward, Ca

• Supported the Analytical R and D group in Generic, solid dose drug Stability and Formulation studies• Performed Dissolution studies using Apparatus 1, 2, 3 and 4 with appropriate buffers • Analyzed samples for API and Impurities by HPLC and UV-Visible spectrophotometry • Recorded data in laboratory notebooks

• Support the Protien analytical Chemistry- Validation Group in Validating test methods• Create Validation Excecution Plans, Validation data Calculation Sheets and deligently record data in ELN in real time • Perform test method Validation under cGMP• Validated the UV -Visible Volumetric method used to quantify protein for commercial BLA submission in a timely fashion• Validated the Reverse Phase HPLC Method to quantify Methionine as an excipient for a Phase III molecule• Performed SEC experiments for Intermediate Precision and Accucacy for commercial BLA submission• Safety co-ordinator for the PAC-V Group

South San Francisco

• Supported the LSPD Group in testing marketed products for stability, Process characterization and Process Validation using various analytical techniques.• Supported in studies involving manufacturing transfer and component change of Activase and TNKase• Independently scheduled and tested Drug product and Drug substance per study protocols, and submited results in a timely fashion• Analyzed data and interpreted results• Recorded Data and Results in electronic notebook (ELN)• Troubleshoot when needed

South San Francisco

Emeryville, Ca

• Performed quality testing of in process bulk, and neutralized bulk drug substance (IFN-1b) for purity by RP HPLC thus increasing efficiency and output by 50%.• Quantified Deamidated IFN-1b in Betaseron® Final container product by Cation Exchange Chromatography.• Served as member of the Safety audit team, and performed monthly lab audits of all the QC Labs in the facility. • Record and Reviewed data in LIMS and Test Record files under strict cGMP regulations• Participate in Deviation, OOS, OOE and OOT investigation and reporting

• Performed validation exercises and qualification of the first validation lots of primers and probes for MRSA, MTB, BCR-ABL and C. difficile.• Worked with the Flu team, quantified the first two sets of primers and probes, and successfully performed final product release testing in a tight timeline. Received commit to action award for extra dedication and effort.• Authored protocol to resolve a CAPA process.• Maintained/Created process and systems in QC to ensure efficiency. • Scheduled testing and reviewed batch records for the QC Group when the supervisor was out of office on an extended leave.

Tested recombinant protein antigen for identity, purity and quantitation by various methods such as HPLC, SDS-PAGE and SDS-CE for Release, In-process and Stability. Performed validation exercises for estimation of PS-80 by spectrophotometry.

Performed amino acid analysis and enzyme inhibition screening by Fluorescent Reverse phase HPLC and 14C- based methods in the Small Molecule Evaluation Group