Staff Fellow Resume Example
Experienced scientific researcher with a wide-ranging skill set including a strong biochemistry and analytical chemistry background in addition to broad expertise in FDA regulation.
|
|
September 2009 to CurrentUniversity Of South Carolina － SC, State
- Review of Chemistry, Manufacturing and Control (CMC) aspects of original BLAs, supplements, Annual Reports and INDs of various Biologics products submitted to the Office of Blood Research and Review
- Writing of memos covering review of process and viral clearance validation, stability, bioburden, sterility, extractable/leachables and other manufacturing processes impacting product quality, safety, potency and efficacy in a timely manner to meet deadlines.
- Participation in meetings (Pre-IND, pre-BLA and other) with sponsor and preparing written responses to sponsor questions pertaining to CMC issues.
- Conducted research involving understanding neutralizing antibodies against Hepatitis C virus
- Developed a luciferase-based binding assay to understand viral antigen, host-cell receptor, and antibody interactions for vaccine design and as early stage potency assay.
- Presented seminars relating to research results and regulatory topics to Division of Hematology
July 1995Massachusetts General Hospital － Natick , MA
- Synthesized peptide analogs containing spectroscopic probes for protein kinase studies.
June 2006 to July 2009The University Of Oklahoma － Norman , OK
- Conducted research to elucidate the processes involved in neurodegenerative and protein aggregation diseases.
- Studies focused on interactions of various proteins involved in the cellular process of ER-associated degradation (ERAD) and ubiquitin-proteasome protein degradation pathways.
- Secondary duties of this position included mentoring graduate students and providing training and guidance to technicians in the laboratory.
January 2006 to June 2006University Of San Francisco － Sacramento , CA
- Conducted structural and function studies of membrane proteins.
- Research involved preparative scale protein expression using baculovirus system and preparative scale purification using various methods such as affinity, ion-exchange and size exclusion.
- Studies also included performing crystallization trials using microbatch and vapor diffusion methods.
January 1999 to January 2005University Of San Francisco － San Francisco , CA
- Thesis/ Dissertation: Studies focused on combining crystallographic techniques and kinetic analysis of substrate and inhibitor complexes with native and mutant Cyclooxygenases in order to understand substrate utilization and drug/protein interactions.
- Studies resulted in two first author publications in the Journal of Biological Chemistry.
- Research included DNA cloning, site-directed mutagenesis, protein expression in various cells lines including bacteria, insect and mammalian cells, protein purification, thin layer chromatography, protein crystallization and structure determination.
January 1998 to January 1999Alpha Teknova Inc. － Hollister , CA
- Studies focused on transcription, purification and crystallization of large catalytic RNAs to understand the mechanism of catalytic RNAs.
January 1997 to January 1998Alpha Teknova Inc. － Hollister , CA
- Method development and validation of analytical HPLC methods for various drug formulations containing multiple drug components.
- Responsible for following GLP and GMP protocols.
- Performed raw materials testing according to USP protocols.
January 1996 to January 1997University Of North Carolina Greensboro － Fort Collins , CO
- Performed USP dissolution assays in combination with quantification of time-released drugs formulations using HPLC methods.
- Performed validation of HPLC methods in compliance with GLP and GMP.
January 1995 to January 1996Southwestern Council For Higher Education － City , STATE
- Synthesis, purification, and characterization of monomeric and polymeric materials at Wright Laboratories/Materials Directorate at Wright Patterson Air Force Base.
•FDA/CBER New Reviewer Training Course: “The Lifecycle Approach” (4 day course) (Jan 14, 2009)
•FDA CBER OCBQ Manufacturing Technology Seminar: Single use upstream manufacturing including purification technologies and extractable leachables considerations (Feb 4, 2010)
•FDA CBER Analytical Technology Series Session 2 Proteomics: Principles and Methods (Feb 23, 2010)
•FDA CBER Manufacturing Process Science: Cell Culture, Fermentation and Bioreactor Technology (July 23, 1010)
•FDA CBER Manufacturing Process Science Series: Introduction to Downstream Processing Chromatography, Filtration, Precipitation & Centrifugation (Sept 23, 2011)
•FDA CBER Fundamentals of Bioassay Practices (Oct 27, 2011)
•FDA OCBQ Manufacturing Technology Seminar: Overview of Viral Clearance Technologies including virus inactivation at low pH, chromatography and nanofiltration (May 10, 2012)
•FDA OCBQ Manufacturing Technology Seminar: Basic Filtration including microfiltration, nanofiltration, and ultrafiltration (July 26, 2012)
•Technical Writing for Reviewers (Sept 10-11 )
•Biostatistics for Non-statisticians (3-day course) (Nov 13, 2012)
•FDA CBER Writing for Success using Plain Language (Mar 27, 2013)
•Basic Principles of Immunology and Hypersensitivity (audit FAES course NIH)
•Principles of Clinical Pharmacology (Clinical Center Sept 2, 2010-April 28, 2011-received certificate for 70% attendance of classes)
- Advisors: William L. Smith and R. Michael Garavito
- Double Bachelors degree in Biology and Chemistry
Harman, C. A., Rieke, C. J., Garavito, R. M., and Smith, W. L. Crystal structure of arachidonic acid bound to a mutant of Prostaglandin Endoperoxide Synthase-1 that forms predominantly 11-HPETE. J. Biol. Chem. (2004), 279: 42429-35.
Harman, C. A, Kozak, K. R, Marnett, L. J., Smith, W. L., and Garavito, R. M. Structural basis of enantioselective inhibition of COX-1 by (S)--substituted indomethacin ethanolamides. J. Biol. Chem. (2007), 282: 28096-28105.
Lim, P.J., Danner, R., Liang, J., Doong H., Harman, C., Srinivasan D., Rothenberg, C., Wang, H., Ye, Y., Fang, S., and Monteiro, M.J. Ubiquilin and p97/VCP bind Erasin, forming a complex involved in ERAD. J. Cell Biol. (2009), 187(2): 201-17.
Duan, H., Kachko, A., Zhong, L., Struble, Evi., Pandey S., Yan, H., Harman, C., Virata-Theimer, M.L., Deng, L., Zhao, Z., Major, M., Feinstone, S., & Zhang, P. Amino Acid Residue-Specific Neutralization and Non-Neutralization of Hepatitis C Virus by Monoclonal Antibodies to the E2 Protein (2012) J. Virology 86(23): 12686-94
Deng, L., Zhong, L., Struble, E., Ma, L., Harman, C., Yan, H., Virata-Theimer, M.L., Zhao, Z., Feinstone, S., Alter, H., & Zhang, P. Structural Evidence for a bifurcated mode of action in the antibody-mediated neutralization of hepatitis C virus (2013) Proc Natl Acad Sci USA 110(18): 7418-22.
Harman, C., Zhong, L., Deng, L., Duan, Hongying, D., Zhong, Z., Ma, L., Liu, Peter., Struble, E., Yan, H., Feinstone, S., and Zhang, P. A View of the CD81-E2 Interface at the Binding Site of a Neutralizing Antibody against Hepatitis C Virus (in preparation 2013)
DISCLAIMER
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
How this resume score could be improved?
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
- Completeness
- Formatting
- Word choice
- Measurable results
- Typos
Resume Overview
School Attended
- Michigan State University
- Wright State University
Job Titles Held:
- Staff Fellow
- Undergraduate Research Assistant
- Postdoctoral Fellow
- Postdoctoral Research Associate
- Graduate Research Assistant
- Analytical Chemist
- Research Assistant
Degrees
- Ph.D : Biochemistry and Molecular Biology , 2005
B.S : Biology & Chemistry , 1996
Similar Resumes
