Life Sciences Quality Control

Dave Jacobs

*** **** *** ***** • New Market, AL • 35761

256-***-**** • ********@*****.***

Analytical and Biochemical Scientist

Journeyman pharmaceutical and biotechnical scientist with experience in academic and industrial research, manufacturing, method and process development and validation. Broad background of analytical chemistry, biochemistry, molecular biology and genetics. Strong working knowledge of GMP/GLP. Proficient with advanced instrumentation and in basic bench chemistry. Routinely multitasks and meets deadlines. Excels at interacting with coworkers of all levels.

Core Competencies

HPLC UPLC/MS GC GC/MS NMR MALDI-TOF X-ray diffraction Differential scanning calorimetry Dynamic vapor sorption Moisture analysis Particle size Thermogravimetric analysis PCR Subcloning Protein expression and purification Enzyme assays lmmunoassays

Professional Experience

Associate Scientist, Nektar Therapeutics, Huntsville, Alabama March 2011-Present

NMR, GC, UPLC/MS, GC-MS, HPLC, TGA, MALDI-TOF. Technical reviewer of all analytical data prior to submission to QA. Analytical lead on certain partner projects. Contributor to multiple Drug Master File submissions/updates. Developed and validated multiple NMR, GC and HPLC methods. Updated GC software platforms, coordinated QC and manufacturing work schedules. Instituted new timeframes for manufacturing sample delivery to expedite production and improve QC scheduling.

Quality Control Chemist, Qualitest, Inc., Huntsville, Alabama 2009-2010

HPLC, GC, manual and potentiometric titrations, DSC; various USP monographs used to measure physical characteristics and verify integrity and identity of raw pharmaceuticals and excipients.

Analytical Research Scientist, Westaff, Inc. for KV Pharmaceuticals, St. Louis, Missouri 2008-2009

Wet bench chemistry and HPLC analysis of in-process materials, stability formulations and finished pharmaceuticals, including controlled substances in tablet, liquid and cream formulations.

Scientist II-IV, Manpower Professional for Pfizer, Inc., St. Louis, Missouri 2004-2008

•Streamlined the process of characterization, purification and distribution of synthetic organic compounds by absorbing the partial or complete functions of five colleagues, freeing others to work on special projects and reducing departmental outlay on headcount.

•Used robotic liquid handling systems and multiplexed HPLC/MS in high throughput characterization and purification of newly synthesized candidate APis.

•Finished construction, directed programming and initiated operation of a salt selection/stable form screening system composed of a robotic liquid handler and PXRD unit

•Used HPLC, PXRD, DVS, TGA, DSC, clEF, and dissolution analyzer to evaluate purity and physical characteristics of candidate APis; HPLC method development.

•Developed and implemented ELISAs for CTX-1 and osteocalcin to track bone remodeling in laboratory test animals' sera.

•Established productive relationships with vendors, CROs, shippers and customs officials to coordinate shipping, receiving, distribution, testing and storage of biologic APis.

Biologist II, Today's Staffing for Monsanto, Inc. St. Louis, Missouri 2002-2004

•Developed methods to produce and purify recombinant proteins and extract and purify its analog from plant tissues; AEX and HIC chromatography, SDS-PAGE, western blots

•Antisera purification and characterization, ELISA development

Senior Research Technician, Washington University School of Medicine, St. Louis, Missouri 1996-2002

•Developed enzyme assay that led to NIH funding, produced and purified substrates and antibodies, generated transgenic C. elegans strains for in situ hybridization and fluorescence microscopy. DNA purification, PCR, sequencing, subcloning and site-directed mutagenesis; SDS-PAGE, western blots.

•Assay/protocol development, data analysis, oral presentations, radiation safety officer, maintenance of plasmid database and frozen stocks, ordering supplies, coordination of equipment service.

Publications

Jacobs, et. al., 1998 Gain-of-Function Mutations in the Caenorhabditis elegans lin-1 ETS Gene Identify a C-Terminal Regulatory Domain Phosphorylated by ERK MAP Kinase. Genetics 149: 1809-1822

Jacobs, et. al., 1999 Multiple Docking Sites on Substrate Proteins Form a Modular System that Mediates Recognition by ERK MAP Kinase.·Genes and Development 13:163-175

Fantz, et. al., 2001 Docking Sites on Substrate Proteins Direct Extracellular Regulated Kinase to Phosphorylate Specific Residues. Journal of Biological Chemistry 276: 272**-*****

Symposia Presentations

"The lin-1 ETS protein is phosphorylated by ERK MAP kinase," 1998 Midwest C. elegans Meeting,

University of Chicago, Chicago, Illinois

"A modular system of docking sites mediates ERK MAP kinase recognition of substrate proteins such as lin-1

and ksr-1," 12!J International C. elegans Meeting, University of Wisconsin-Madison, 1999

Education

B. S Physics, Magna cum Laude, 1989, University of Missouri-St. Louis Graduate studies in Physics, 1989-1990, University of California, Irvine

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