GOPA MITRA GOPA MITRA 1207 NORTON STREET (650) 345-8348 SAN MATEO, CA 94401 gm13cbd7a@westpost.

net PROFESSIONAL SUMMARY: Results-oriented scientist with experience in research and product development, on-market product support, validation and commercialization of biotechnology products. * Product development: Developed and optimized genetic and cell a"based biological assays, reagents and diagnostic kits for life science research market from development to launch phase following design control guidelines. * Manufacturing Transfer: Wrote quality control test procedures, manufacturing documents, set QC specifications, transferred technology to Manufacturing group * Technical support for customer complaint resolution: Designed, executed and analyzed trouble-shooting experiments to resolve customer complaints. * Validation: Performed genetic analysis assay, reagent and kit validation to ensure that products are fit-for-purpose for Human Identification and Pharma customers. SKILLS SUMMARY * In depth hands-on experience with various molecular biology and cell biology techniques, genomic and cell based assay development, reagent development and diagnostic kit manufacturing * Experienced in gene cloning, mammalian cell culture, expression and purification of recombinant proteins, , antibody purification and characterization, immunoassays (SDS-PAGE, Western Blot, ELISA), fluorescent immuno-cytochemistry, enzyme kinetics, fluorescence microscopy * Experience with DNA/RNA isolation, hybridization, labeling, DNA sequencing, PCR primer design, gene expression applications, q-PCR, SNP Genotyping, HRM analysis, mutation detection * Extensive experience with real-time multiplex PCR chemistry,

instrumentation and software * Knowledgeable in GLP, cGMP, ISO9001, ISO 13485, FDA-QSR (21 CFR 820) WORK EXPERIENCE: LIFE TECHNOLOGIES INC, FOSTER CITY, CA 8/ 08-10/10 VALIDATION AND PRODUCT APPLICATIONS SCIENTIST * Validate and optimize microbial detection and pathogen identification assays using DNA cycle sequencing and real-time PCR (Taq-Man) assay * Validate human identification assays used by crime scene investigation labs (nucleic acid sample preparation, DNA quantitation by q-PCR and multiplex STR assays) using AB capillary electrophoresis and real-time PCR instruments. * Troubleshoot AB diagnostic assay kits and reagents for customer support/complaint resolution, implemented improvement activities related to complaints. * Integrate assay chemistries and instruments, validate kit reagents, polymers, arrays and software changes, instrument performance validation, reagent stability studies. * Prepares experimental protocols, test plans, interpret and analyze large and complex data sets using statistical parameters using Excel, JMP, Minitab, generate reports. * Present technical data to project teams, stay current with relevant literature/scientific topics * Work with Research, Operations and Marketing groups. SYNARC, INC, SAN FRANCISCO, CA 7/07- 7/08 CLINICAL RESEARCH SPECIALIST * Review, process, track and manage clinical data * Ensure validity of study information by monitoring and tracking clinical study data to identify/resolve discrepancies and obtain missing data

* Generate queries, follow-up and resolution of issues. * Preparation of study materials during study start up phase of clinical trial, insure adherence to study protocol, generate site and patient reports and distribute to clinical sites, performs study close-out activities. * Manage and schedule logistical and technical trainings with clinical sites. * Electronic data capture using clinical soft wares. NEKTAR THERAPEUTICS, SAN CARLOS, CA 3/06-2006 (CONTRACT) PROJECT COORDINATOR * Developed project plans, schedules and resource requirements for preparation of a Investigational New Drug Application regulatory submission * Tracked project interdependencies, milestones and deliverables * Tracked project tasks against timelines, prepared status reports, facilitated meetings, distributed minutes, followed up on action items, worked with Contract Research Organizations GENENTECH INC., SOUTH SAN FRANCISCO, CA 3/05- 5/05 (CONTRACT , ADECCO TECH) REGULATORY AFFAIRS Responsible for CMC regulatory research on stability studies for drug products and drug substances, expiration dating changes, manufacturing process changes, Changes Being Effected , gathering information and assembling Annual Reports for submission to FDA. ABBOTT DIAGNOSTICS, SANTA CLARA, CA 4/2004- 2004 (CONTRACT) SR. SCIENTIST, REAGENT DEVELOPMENT *

Develop reagents, controls and consumables for Abbott Cell Dyn 3200 hematology analyzer * Troubleshoot reagents to resolve customer complaints. APPLIED BIOSYSTEMS, FOSTER CITY, CA 3/1999 a" 2003 SENIOR SCIENTIST, CONSUMABLES DEVELOPMENT * Developed assay specific reagents, kits and commercialized products from development to launch phase following ISO9001 compliant design control guidelines, drafted manufacturing and quality control test procedures (SOPs), transferred technology to Manufacturing group. * Troubleshoot customer complaints and provided failure investigation reports. * Managed project life cycle for multiple projects including work plan creation and deliverables tracking; set up product development infrastructure ( Bill of Materials, Batch Records), used LIMS, SAP, worked with cross-functional project teams , supported project teams by creating and managing project timelines, document change control and maintained project history files. * Developed and optimized DNA sequencing reagents for Big-dye terminator cycle sequencing, optimized High through-put Single Nucleotide Polymorphism detection assay using MALDI-TOF mass spectrometry and capillary based DNA electrophoresis system, fluorescent dye conjugated oligonucleotide matrix standards and size standards, real-time RT-PCR based gene expression profiling, food pathogen detection assay using TaqMan probes and primers, fluorescent PCR based Amplified Fragment Length Polymorphism assay for microbial and plant fingerprinting * Analyzed technical data, set up in-process QC tests and specifications, stability studies, performed process optimization and prepared validation reports. PROMEGA CORPORATION, MADISON, WI. 1/93 - 1998 SENIOR SCIENTIST, R &D * Developed In situ and biochemical in- vitro cell- based assays for detection and quantitation of cellular apoptosis, cell proliferation assay, kinase assay and reporter gene assay *

Developed polyclonal antibodies and immunoassays (SDS-PAGE, CE, ELISA, fluorescent immunostaining, IHC, immunoprecipitation, Western Blots, Chemiluminescence) * Developed and implemented strategies for cloning, expression of eukaryotic proteins in bacteria and mammalian cells, small scale protein purification, mammalian cell culture, DNA transfection in mammalian cells. * Wrote and edited Manufacturing SOPs, scale up procedures, technical literature, user guides. * Trained Technical Services Representatives on the use of new products and technologies for the purpose of providing customer support. . Education Ph.D. Biochemistry, Calcutta University, India Thesis: Biochemical action of cannabis (delta a"9-tetrahydro-cannabinol) on hepatic microsomal drug metabolizing enzymes of rats. SPECIAL TRAINING San Jose State University 2005 -Project Management Certificate University of California Santa Cruz Extension a"Courses taken-2007-2008 -Good Clinical Practices -Good Manufacturing Practices -Clinical Biostatistics for Non Statisticians -Interacting with FDA -Drug Development Process -Bioinformatics Experienced in MS Word, Excel, Power Point, Project, Outlook, ABI 370, 310, 3100, 3130XL, 7500, ViiA7 instruments, Bio-Rad CFX 384 and Roche LC480, MiniTab 15, Microseq ID, GeneMapper ID-X, fluorescence microscopy, MALDI-TOF MS