You are on page 1of 3

JAMES WANG, PHD 428 Felton Ave, Highland Park, NJ 08904 Cell: (848)-391-2205 Email: jw97ffb@westpost.

net SUMMARY OF QUALIFICATIONS A biopharmaceutical scientist with managerial experience in GMP manufacturing, k nowledge of CMC contents, and IND preparation and submission: Established and im plemented SOPs and in-process QC. Developed manufacturing processes and batch re cords. Supervised documentation of manufacturing batch record and manufacturing derivations (MDR). Monitored and enforced project milestones and deliverables in ternally and externally by CROs. Strong background of molecular virology and bio technology including reverse genetics of in mammalian cell systems and subunit v accine expression using transgenic and viral vector-based plant systems. Knowled ge of FDA, WHO and ICH guidelines. Effective multi-tasker with careful attention to detail. Excellent interpersonal, team building and communication skills. Vis ionary, leadership, analytical, problem-solving and efficient; Permanent reside nt of the US. AREAS OF EXPERTISE Mammalian cell culture, reverse genetic rescue of influenza virus, fluorescence foci assay (FFA), aseptic operation under GMP conditions, medium simulation of m anufacturing process, bubble point test, batch record documentation, manufacturi ng deviation report (MDR) documentation, in-process quality control (QC), SOP de velopment and implementation, corrective action and preventive action (CAPA) ini tiatives and implementation, process development, and viable and non-viable envi ronmental monitoring. Molecular biological and biotechnological techniques, incl uding plant genetic transformation and viral vector construction, agrobacterialmediated transient expression, RNA interference (RNAi), protein expression in E. coli and baculovirus systems, protein purification using affinity tag, viral ex pression vector construction. Industrial marketing skills including project mana gement, CRO customer interaction. PROFESSIONAL EXPERIENCE VIVALDI BIOSCIENCES INC, New York, NY GMP Manufacturing Manager (Sept, 2008 - Present) Vivaldi Biosciences is a biopharmaceutical company developing live attenuated in fluenza vaccine (LAIV) using a novel technology platform. Vivaldi's pre-clinical and clinical trial materials are manufactured in its own GMP facility situated in New York City. * Designed and established a GMP manufacturing facility for LAIV production. * Monitored and enforced project milestones and deliverables against timelines. * Directed GMP manufacturing of pre-clinical and clinical trial materials of 2 L AIVs. * Supervised GMP manufacturing operation, in-process QC, on-site CAPA. * Created and implemented SOPs, manufacturing batch records and change control d ocumentation. * Designed and implemented manufacturing processes of LAIV including formulation and filling. * Knowledge of FDA, ICH and WHO guidelines and CMC contents for vaccine developm ent. * Rescued several engineered influenza viruses using reverse genetics system and tittered by FFA. GENSCRIPT CORPORATION, Piscataway, NJ Scientific Quality Control Manager (March, 2007 - Aug, 2008) GenScript is a biotech company and contract research organization (CRO), providi ng molecular biology and immunology reagents, assay kits and research services t o pharmaceutical and biotechnological companies, and research institutions world wide.

* Doubled revenue by technical internet marketing of biological research product s and services. * Directed corporate scientific QC activities in internet marketing strategy dev elopment. * Supervised scientific accuracy of corporate websites for molecular biology rea gents and services. * Acted as a technical specialist of a novel breakthrough western blotting techn ology. * Established SOPs and a checklist tool for technical description of biological reagents and assay services. * Published 2 notes in Nature for new product focus on RNAi and a line of novel western blot kits. * Designed and conducted experimental investigations of root causes in derivatio ns of reagent application. * Taught team members basics of molecular biology and immunology and impact scie ntific writing. BOYCE THOMPSON INSTITUTE FOR PLANT RESEARCH (BTI), CORNELL UNIVERSITY, Ithaca, N Y Postdoctoral Research Associate (May, 2004 - Feb, 2007) BTI is a non-profit research institution, its research aims to increase world fo od supply, enhance the nutritional value of foods, improve environment, and prod uce more affordable vaccines. * Positioned NO (nitric oxide) induction in signal transduction pathways of plan t disease resistance. * Developed a novel NO biological reporter system for high throughput screening (HTS). * Characterized novel biological NO detection system using confocal microscopy. * Conducted gene functional analysis using RNA interference (RNAi) and biochemic al assay. * Expressed and purified a recombinant mitochondrial P protein in E. coli or bac ulovirus system. * Investigated NO-producing enzymatic activity of purified P protein using EPR a nd Griess assay. * Localized mitochondrial gene expression level by analyzing co-expressed GUS en zymatic activity. EDUCATION HEBREW UNIVERSITY OF JERUSALEM, Israel Doctor of Philosophy: Molecular Virology SELECTED PUBLICATIONS [1]. Moreau, M., Lee, G-I., Wang, Y., Crane, B. R. and D. F. Klessig (2008) AtNO S/A1 is a functional Arabidopsis thaliana cGTPase and not a nitric oxide synthas e. Journal of Biological Chemistry 285: 32957-32967. [2]. Carr, T., Wang, Y., Huang, Z., Yeakley, J-M., Fan, J-B., SA. Whitham (2006 ) Tobamovirus infection is independent of HSP101 mRNA induction and protein expr ession. Virus Research 121(1):33-41 [3]. Wang, Y., Tzfira, T., Gaba, V., Citovsky, V., Palukaitis, P. and A. Gal-On (2004) Functional analysis of the cucumber mosaic virus 2b protein: pathogenesis and nuclear localization. Journal of General Virology 85: 3135-3147. [4]. Whitham, S. A. and Y. Wang (2004) Roles for host factors in plant viral pa thogenicity (Review). Current Opinion of Plant Biology 7(4): 365-371. [5]. Wang, Y., Lee. K. C., Gaba, V., Wong. S. K., Palukaitis, P. and Gal-On, A. (2004) Breakage of resistance to Cucumber mosaic virus by co-infection with Zucc hini yellow mosaic virus: enhancement of CMV accumulation independent of disease symptoms. Archives of Virology 149:379-396. [6]. Wang, Y., Gaba, V., Yang, J., Palukaitis, P. and Gal-On, A. (2002) Characte rization of synergy between Cucumber Mosaic Virus and potyviruses in cucurbit ho sts. Phytopathology 92:51-58.

[7]. Shalitin, D., Wang, Y., Omid, A., Gal-On, A. & Wolf, S. (2002) Cucumber mos aic virus movement protein affects sugar metabolism and transport in tobacco and melon plants. Plant, Cell & Environment 25:989-997. [8]. Antignus, Y.*, Wang, Y.*, Pearlsman, M., Lachman, O., Levy, N. and Gal-On, A. (2001). Biological and molecular characterization of a new cucurbit-infecting tobamovirus. Phytopathology 6:565-571. (*These authors contributed equally). [9]. Wang, Y., Gaba, V., Wolf, D., Xia, X., Zelcer, A. and Gal-On A. (2000). Ide ntification of a novel plant virus promoter using a potyvirus infectious clone. Virus Genes 20: 11-17. PROFESSIONAL AFFILIATION American Society for Virology (ASV) Technical Sales Association (TSA) COMPUTER SKILLS Microsoft Word, Excel and PowerPoint, Project; Photoshop; Vector NTI.