• Leading QC initiatives for commercial and phase III projects.• Oversee release testing of Drug Substance, Drug Product and In-process Samples and Stability programs conducted at CMO/CLO.• Responsible for On-soil testing for new market expansion and post-approval commitment as per FDA, ANVISA, ANMAT, TMoH, K-DMF and PMDA requirements.• Worked collaboratively with a cross functional team including Quality Assurance, Regulatory Affairs and Supply Chain on QC release testing and batch release updates due to Brexit and the MRA between Japan and European Union.• Worked closely with Clinical operations team and Regulatory Affairs on RBA study, IMPD and NDA submission.• Evaluated data with JMP and Minitab for trends indicative of product performance and method performance and worked with CMO’s to set trend limits for all analytical methods and responsible for self-life assessments and extension of expiration dating.• Responsible for method qualification/validation/feasibility/tech transfer activities conducted at various CMO.• Experienced in driving CMO’s quality events like deviations, OOS and OOT laboratory investigations paper based and by TrackWise system.• Assessed and documented all proposed changes to the analytical methods and specifications through change control system.• Authored Quality Control SOPs, protocols and reports in accordance with cGMP regulations.

• Evaluated and designed client’s molecular biology and peptide reagent requirements and facilitated the order.• Documented the project requirements in the eDMS and transferred to the production team.• Maintained business opportunities in Microsoft dynamic CRM and created a dashboard with performance metrics.• Analyzed DNA or protein sequence for gene synthesis or for mutagenesis and optimized codon for better protein expression and cloned in the client’s preferred vector.• Identified client’s CRISPR research and ORF cDNA clone needs and educated about Genscript’s product.• Analyzed sales trends in the assigned region and forecasted the business demands.

Scientist-IV, Assay Development● Worked in a novel CTC isolation instrument and in-charge of collection and processing of prostate cancer patient sample to isolate Circulating Tumor Cells (CTC).● Responsible for picking single cell from CTC isolator’s output for molecular analysis.● Performed automated multiplex staining of the CTC output in Leica Bond RX.● Performed manual IHC staining of the CTC output and the cell culture samples to evaluate the antibody interaction.● Performed cell imaging with Perkin elmer Vectra and ALS cell imaging.● Successfully completed a clinical study to evaluate the performance of a novel, PCR based all-in-one cartridge assay capable of determining the presence of HIV-1 RNA and wrote a protocol for the collection and processing of the clinical patient samples.● Analyzed the data trend of internal assay with Spotfire and compared with the results of the clinical sample provider and designed further experiments for PCR optimization.Ortho Clinical Diagnostics, Scientist, Bioformulation /Antisera● Responsible for formulation of ELISA conjugates and controls for HCV, HBV and T.cruzi and confirmed performance by manual ELISA test.● Perform Radio Immuno Diffusion assay to assess the performance of the antigen antibody interaction.● Assist in gel electrophoresis to assess the purity of the IgG and IgM antibodies.● Analyzed the performance of Anti-human globulin in Biovue and by tube agglutination method.Scientist, R&D, Molecular Assay development● Regularly ran PCR experiments, analyzed the data and graphed it in Excel, Minitab or Spotfire.● Designed a sandwich ELISA to test the drugs in blood sample.● Optimized the assay by trying different plates and conditions for coating the drug antibody conjugate.● Compared the kinetics of the antigen and antibody interaction in Biacore and manual ELISA and read the plate in Tecan● Mammalian cell culture, extraction of DNA and RNA.

● Supported Quality control and assay development group in laboratory investigations, technology transfer, validation and qualification of various molecular assays.● Performed release test and the stability test for various Roche assay specific reagents and controls.● Analyzed all the data, trended the values and proceduralized trend limits for various analytical methods.● Documented in accordance to cGMP and GDP regulations in Batch Test Record (BTR) and managed the data in LIMS.● Manufactured laboratory scale internal controls and authored Certificate of Analysis, SOP and investigation reports.● Executed PCR and ELISA based test in various Roche instruments like Cobas Ampliprep, Taqman and nucleic acid extraction using High Pure system and Cobas Taqman 48 Analyzer.● Processed clinical samples with Cobas Amplicor monitor test by Standard and ultra-sensitive method and used Cobas Amplicor Analyzer for amplification and detection, with Multiplex capability for CT/NG assay.