Analytical Biochemist
Resume:
TIMOTHY WAGNER
Analytical Biochemist
***********@*****.***
Durham, NC 27705
Analytical biochemist with sixteen years of experience focused in the biotechnology industry. Expertise centers on biomolecule characterization, assay development, qualification/validation, and technical transfer to QC. Interested in expanding laboratory skills to proteomics and DNA/RNA technologies. Strong background in HPLC, immunological methods and proteomics.
LABORATORY SKILLS
Normal and reversed phase HPLC
IEX and SEC HPLC
Evaporative Light Scattering detection
UV detection
Fluorescence detection
Refractive Index detection
Western blotting
Southern blotting
Agarose gel electrophoresis
SDS-PAGE
UV-Vis spectroscopy
Fluorescence spectroscopy
Capture ELISA
Indirect ELISA
BCA protein assay
Immunofluorescence Assay
Hybridoma cell culture
Aseptic technique
Statistical data analysis
Solid phase extraction
DNA/RNA purification
CAREER HIGHLIGHTS
Isolated and separated Venezuelan equine encephalitis nucleocapsid and glycoproteins by HPLC
Developed and qualified two capture ELISAs to measure protein expression of RNA encapsulated virus-like particles in Vero cells
Created and optimized an HPLC-ELSD method to extract and quantitate sucrose in a formulated product bulk containing albumin and cellular proteins
Wrote, edited and signed STMs, SOPs, development reports, qualification/validation protocols and summary reports for methods and instrumentation supporting clinical trials and product launch
PROFESSIONAL EXPERIENCE
ALPHAVAX HUMAN VACCINES | Research Triangle Park, NC 2000 – 2010
Senior Development Associate Scientist II (October 2006 – February 2010)
Responsible for the development, qualification and technical transfer of LC and antibody based methods in support of quality control, manufacturing and development groups. In charge of generation and characterization of nucleic acid standards for use in gel based and qPCR based assays.
Sourced and Screened monoclonal antibodies for use in analytical assays (ELISA, IFA, Western Blot)
Developed, optimized, validated and performed tech transfer for protein expression ELISA methods
Created LC based method to isolate and quantify sucrose in formulated product by HPLC-ELSD
Characterized common phospholipids with HPLC-ELSD
Developed methods to quantify host cell proteins and nucleic acids in a virus-like particle preparation
Qualified and validated methods, designed and wrote SOPs, standard test methods, development reports, and validation protocols
Presented data at group meetings and company project updates
Adhered to cGMPs for documentation, instrument maintenance and data presentation
Senior Development Associate Scientist (September 2000 – October 2006)
Developed HPLC method to isolate and characterize structural proteins in determination of virus-like particle concentration
Developed HPLC method to quantitate Human Serum Albumin in product formulation
Directed technical transfer of release methods to QC groups (ELISAs, HPLC, BCA, Anthrone)
Developed, qualified and transferred Immunofluorescence based potency assays to QC
Supported Phase I/II clinical trials with release assay testing and stability testing following cGMP guidance
Analyzed proteins in product and formulation by ELISA, HPLC, and BCA
Initiated and qualified a Southern blot method for measuring residual Vero DNA size in upstream process samples
WYETH VACCINES | Sanford, NC 1996 – 2000
Scientist II (September 1996 – September 2000)
Responsible for the development and validation of quantitative protein and saccharide assays in support of stability programs, Phase II/III clinical trials and the Prevnar® pneumococcal vaccine product launch.
Characterized proteins and saccharides for new vaccine products
Performed stability testing for development projects
Initiated experiments for assay development and validation
Wrote protocols for instrument qualification and assay validation
Maintained repair of laboratory equipment
Followed cGMPs for release tests
Trained new employees on test methods
Contract Research Associate (June 1996 – September 1996)
ENVIROSTAFF, INC. | Detroit, MI 1995 – 1996
Contract Laboratory Technician
WAYNE STATE UNIVERSITY | Detroit, MI 1994 – 1995
Research and Teaching Assistant
PARKE-DAVIS PHARMACEUTICALS | Ann Arbor, MI 1994
Summer Research Intern
LEINER HEALTH PRODUCTS | Kalamazoo, MI 1993 – 1994
Research and Development Chemist
EDUCATION
B.A., Chemistry
Adrian College, Adrian, MI
Course: Analytical Characterization of Glycosylation in Glycoproteins; June 2006
Course: Agilent Q-TOF LC/MS Techniques and Operation Training; July 2008
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