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Analytical Development │ Principal Scientist

Results-oriented, Principal Scientist with demonstrated initiative, creativity and leadership, with expertise in advancing new strategic directions in world-class institutions.

Exceptional Principal Scientist with advanced degrees, exceptional technical skills, practical experience and comprehensive understanding of the unlimited commercial potential and humanistic value of Pharmaceutical and Analytical research and development activities. Demonstrated experience in planning, conducting, managing and documenting full-scale project lifecycles. Proven experience in achieving technical, productivity and quality goals.

PROFESSIONAL EXPERIENCE
Principal Scientist – Momenta Pharmaceuticals (Quality Control) 2010 to 2011
 Provide strategic scientific oversight of analytical assays transferred into Quality Control with focus on bioassays and immunoassays.
 Strategic generalized statistical support for Quality Control (stability data guidance, trend analysis).
 Manage external contract research laboratory activities for anti-Xa-IIa activity assays.
Senior Scientist – Shire Pharmaceuticals Inc. Human Genetic Therapies 2006 to 2010
 Established and led new bioassay infrastructure initiatives for Pharmaceutical and Analytical Development (PAD) department.
 Successfully designed and implemented bioassay and cell culture automation strategies, novel cellular uptake and substrate depletion assay methodologies .
 Managed group of scientists and associates that directed bioassay development, qualification, and validation activities, and member of the CTD leadership team.
 Provided general statistical support for all PAD analytical functions, and assisted in calculation of analytical method specifications, process capability, method validation, and qualification design.
 Performed troubleshooting and analytical characterization using DOE and variance components analysis across assays supporting regulatory submissions and authorship of relevant sections of the common technical document (CTD) per ICH guidelines.
Senior Associate Scientist/Supervisor, Bioassay Development – Biogen Idec 2002 to 2006
 Led bioassay development group, and established new automated bioassay development platform (fully randomized bioassay models) for the Clinical Science and Technology division.
 Utilized advanced bioassay development approaches (DOE), and fractional factorial design, response surface methodology.
 Oversaw cell based assay development, Kinase receptor activation assay (KIRA), cell adhesion assays, reporter gene assays, cell bridging assays, and Cytotoxicity assays.
 Led Immunoassay development, as a bioassay quantification tool, and competitive-inhibition immunoassay using cellular lysates.
GD Searle (Monsanto then Pharmacia) 1997 to 2002
Scientist, Bioassay Development Team Leader (2000 to 2002)
 Led bioassay development activities and managed bioassay lab.
 Successfully automated bioassay development, all aspects from statistical analysis to cell line procurement and development and eventual cGMP validation.
 Provided cell based assay development, cell proliferation assays, growth inhibition assays, homogenous immunoassay using bead based technologies, and Cytotoxicity assays.

Co-manager, Pharma Biologics cGMP Analytical Lab (PBAL) (1998 to 2000)
 Established (from design of structure and lab design) of cGMP bioassay laboratories (PBAL) -cGMP bioassay supervision and performance, and cGMP bioassay development Cell culture.
 Provided SOP documentation writing and review, spreadsheet design, and assay automation using the Beckman biomek and zymark robotics, and supervised QC bioassay analysts.
Scientist, Assay Development (1997to1998)
 Developed of cell proliferation bioassays, ELISAs, Neutralizing antibody screening assays —-Assay validation.
 Supported additional GD Searle cytokine projects, cell line procurement and assay development, and various HPLC and Affinity chromatography that included building polyclonal Ab columns and protein purification.

 Provided data analysis that included statistics package development with staff statisticians, and high throughput assay advent and development (immediate early gene expression); Taq-man primer-probe research and design using primer express.

EDUCATION / AFFILIATIONS / HONORS & AWARDS
M.S. Biological Sciences – Southern Illinois University, Carbondale, IL, 1997
B.S. Physiology – Southern Illinois University, Carbondale IL, 1994
Concentrations: Cell Culture, Neuropharmacology, Neuroendocrinology, Pharmacology
Thesis title: Comparative Neurite Extension of Developing Fetal Locus Coeruleus Neurons Taken from Genetically Epilepsy-Prone Rats (GEPRs): an in vitro study.

Affiliations:
U.S.P. Expert Committee Member and Co-author of new Bioassay Validation and Bioassay Design Chapters, 2003-current (PF 36(4))
Numerous IBC, USP, and Well Characterized Biologicals faculty assignments (listed below)

Honors and Awards:
Shire Impact Award 2010
Shire Legacy Award 2007
Outstanding Achievement Award, G.D. Searle, December, 1997

ACADEMIC LABORATORY EXPERIENCE
SIUC School of Medicine -Dept. of Anatomy 1995 to 1996
Dr. Richard Clough, Neuroanatomy Lab.
 Primary cell culture of fetal brain tissue using both explant and cell dispersion techniques; Immunohistochemistry (tyrosine hydroxylase and c-fos); Small animal surgery; Microscopic neurosurgery to secure fetal rat target tissues; Computer-aided morphometry of neurite extension; Light microscopy; Data analysis; Experimental design and implementation; Publication authorship/submission and subsequent defense (to editorial board).
SIUC College of Science – Dept. of Microbiology 1996
Dr. John Martinko, Dept. of Microbiology Chairman.
 Design and implementation of immunoassay for kidney tissues (staining for immune-complexes) in aging transgenic-mice (MTbGH-20); computer-aided arbitrary densitometric measurement, histology techniques; vibratome, cryotome, hematoxylin and eosin staining, immunohistochemistry.
SIUC School of Medicine -Dept. of Physiology 1995
Dr. Rick Steger, Neuroendocrinology Lab.
 Procurement and HPLC-EC of brain tissue homogenates; small animal surgery; data analysis; scientific contribution.
SIUC School of Medicine- Dept. of Physiology 1992 to1995
Dr. Andrzej Bartke, and Dr. Charles Meliska, Reproductive Physiology Lab.
 Laboratory supervisor; Quantitative evaluation of reproductive and grooming behaviors in transgenic mice; ovariectomy; silastic capsule implantation; orchidectomy; data organization and analysis; scientific contribution.

TEACHING EXPERIENCE / GRADUATE APPOINTMENTS
Teaching Assistant, SIUC Dept. of Zoology, 1996 │ General Biology (GEA 115) laboratory sections 2, 5, and 7
High School Biology 1, Biology 2, Physical Science.

Graduate Appointments:
Research Assistant – SIUC School of Medicine, Dept. of Anatomy 1995 to1996
Teaching Assistant – SIUC College of Science, Dept. of Zoology 1996
QbD │ PAT │ PTI │ JMP software application and inferential statistics
Successfully Managing People, American Management Association
cGMP basics: Audit Preparation, cGMP Institute │ Leading for Quality, cGMP Institute
cGMP computer compliance, Pharmacia Corp.
Introduction to Experiment Design and AAO FX Software to include fractional factorial analysis, central composite design, and surface modeling (DOE).

EXTERNAL PUBLICATIONS
1. Boris Brumshtein, Paul Salinas, Brian R Peterson, Victor Chan, Israel Silman, Joel L Sussman, Philip J Savickas, Gregory S Robinson, and Anthony H Futerman (2010) Characterization of gene-activated human acid-β-glucosidase: Crystal structure, glycan composition, and internalization into macrophages. Glycobiology vol. 20 no. 1 pp. 24-32

2. Clough, R.W., Peterson, B.R., Steenbergen, J.L., Jobe, P.C, Eells, J.B., Browning, R.A., Mishra, P.K. (1997) Neurite extension of developing noradrenergic neurons is impaired in genetically epilepsy-prone rats (GEPR-3s): an in vitro study on the locus coeruleus. Epilepsy Research, January, 1998; 29(2): 135-146

3. Clough, R.W., Peterson, B.R., Eells, J.B., Steenbergen, J.L., Mishra, P.K., Jobe, P.C. (1996) Neurite arborization of fetal locus coeruleus (LC) neurons in vitro: Analysis of substrates, cytosine- arabinofuranoside, and co-cultures in preparation for studies on epilepsy. Society for Neuroscience Abstracts, vol. 22, No. 819.1

4. Clough, R.W., Peterson, B.R., Eells, J.B., Browning, R.A., Steenbergen, J.L., Mishra, P.K., Jobe, P.C. (1997) Noradrenergic abnormalities in genetically epilepsy-prone rats (GEPRs) may result from deficient arborization of developing locus coeruleus (LC) neurons: an in vitro study. Society for Neuroscience Abstracts, vol. 24, No. 750.5

EXTERNAL PRESENTATIONS
 Bioassay Automation and use of Robotics for Cell proliferation Assays, Bioanalytical Conference, Chicago IL, 2000
 Bioassay Automation and the Use of Immunoassay or Binding Assay Models for QC Bioassay Release Assays in Compliance with ICH Standards, Biopharm, IBC Life Sciences Professional Development Course: Development and Validation for the Real Scientist, San Francisco, 2002
 The use of Fractional Factorial Analysis and Response Surface Modeling in the Development of Automated Bioassays, IBC conference: Bioassay Development, Washington DC, 2003
 Strategy for the Validation of Biological Assays, USP conference on biologics, November 2003
 Design of Experiments (DOE) as a Bioassay Development Tool, IBC conference, bioassay development, Berlin, Germany 2004
 USP Writing the New Bioassay Validation Chapter, IBC conference, bioassay development, Berlin, Germany 2004
 Design of Experiments (DOE) as a Bioassay Development Tool, IBC conference,
 Well Characterized Biologicals, Washington D.C., 2004
 Design of Experiments (DOE) as Bioassay Development Tool, IBC conference, bioassay development, Boston, 2005
 Design of Experiments: understanding the factorial approach , BPI analytical and quality summit, La Jolla, 2007
 Biological and Statistical Considerations for Successful Bioassay Method Transfer and validation, IBC conference, San Diego, 2008
 Introduction to the new Bioassay Design Chapter , USP Bioassay Conference, Bethesda, 2009
 Novel Bioassay Platform Utilized to Elucidate Increased Rate of Cellular Internalization of glucocerbrocidase alfa (VPRIV) compared to Cerezyme. EWGGD, Cologne Germany, 2010

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