Quality Control Technician

ROBIN M. SMITH

** ********** ****** . *********, ** 01604-4764 . cell: 774-***-****. home:

508-***-****

E-mail: *********@*****.***

SUMMARY: Highly skilled research associate with academic and industry

experience in molecular and cell biology, immunology, protein engineering

and regulated preclinical bioanalysis of biotherapeutics. Demonstrated

self-motivation, flexibility and adaptability. Excellent time management

and multitasking skills, with the ability to function independently and

cooperatively in a dynamic, timeline driven environment.

TECHNICAL SKILLS:

Recombinant DNA techniques- Cloning: PCR/RT-PCR, restriction enzyme

digestion, ligation, transformation, homologous recombination, colony

screening, primer design, DNA purification, gel electrophoresis, in vitro

translation, sequence analysis.

Molecular Biology - Bacterial one and two hybrid selections, phage display,

construct bacterial strains and randomized codon libraries, preparation of

bacteriophage, as well as chemically and electrocompetent E.Coli,

electroporations and transient transfections.

Cell culture - Mammalian and bacterial cell culture, fermentations,

initiation of primary cell cultures, PBMC isolation.

Immunology- ELISA (MSD chromogenic and chemiluminescent), biomarker and

cell based assays, multiplex flow cell fluorimetry (Luminex),

immunoprecipitation, Western blot, FACS

Biochemistry- SDS-PAGE, affinity and size exclusion chromatography,

enzymatic assay.

In vivo- rat and mouse gavage, injections, dissections, necropsy, isolated

liver perfusions.

Computer- Microsoft Office, Filemaker Pro, Vector NTI, Sequencher,

Macvector, DNA Strider, Codoncode Aligner, FloJo, CellQuest, Graphpad

Prism, LIMS,Nautilus, Isotrain, SharePoint, SoftMax GXP, E-Workbook Suite.

EXPERIENCE:

Abbott Bioresearch Center (Abbvie as of 1/2013), DVD-Ig group, Worcester,

MA 2011-2013

Biologist II- contract position through Manpower /Experis

. Re-engineered and cloned pHybE and CHO expression vectors to create

panels of target specific DVD's with various combinations of VH, VL and

linker, followed by "gold standard" sequence confirmation.

. Assisted in the initiation of high throughput rat hybridoma de novo

cloning method of antibody variable domain sequences.

. 5'RACE cloning of novel antibody variable domains from rat hybridomas

with sequence determination, primer design and cloning into expression

vector, transient transfection into HEK293, purification, screening and

characterization of the antibodies.

. Functional analysis of antibody batches using L929 / TNF-? neutralization

assay and target/Ba/F3 FACS binding analysis.

. Maintained cell lines for functional assays. Maintained and harvest

transfected CHO cell lines for antibody production.

. Recorded experiments and results in electronic laboratory notebook

format according to company policy.

. Attended group, department and company meetings. Trained associate

in molecular biology techniques.

Acceleron Pharma, Bioanalytical Development, Cambridge, MA

2011

Research Associate- 3 month contract through StratAcuity Scientific

Staffing

. Analyzed samples by ELISA for preclinical pharmacokinetic and

immunogenicity studies.

. Tabulated and reviewed ELISA data, and performed quality control of

data package.

Abbott Bioresearch Center, Antibody Generation Group, Worcester, MA

2010

Biologist II- 3 month contract through Manpower Professional

. Provided technical support for the identification and conversion of

target specific antibody candidates from mRNA library selections.

. Transformed libraries into expression vectors, used robotics to pick

colonies for PCR, culture, and for in vitro transcription/translation of

the PCR products. ELISA screened and purified DNA of selected clones,

performed DNA sequence analysis, cloned new vector constructs.

ROBIN M. SMITH ? cell: 774-***-****? home: 508-***-**** ? E-mail:

*********@*****.***

Charles River Laboratories-PCS_MA, Immunobiology, Shrewsbury, MA

2007-2010

Research Specialist

. Promoted from Research Associate to Research Specialist in 2008

. Assisted in method development and validation of ELISA assays, and

performed ELISA sample analysis with SoftMax data capture for

immunogenicity, PK, and TK preclinical studies in strict compliance with

SOP's and GLP regulations.

. Recorded, peer reviewed, and performed quality control of project data in

accordance with GLP regulations for inclusion in data packages and

laboratory methods.

. Wrote laboratory methods and created forms to record data and procedural

information.

. Performed monthly equipment verifications and laboratory maintenance in

compliance with GLP policy.

. Isolated and processed cynomolgus PBMC from TK/PK study time point whole

blood samples.

. Multicolor FACS staining of PBMC.

. Prepared, aliquoted, and electronically tracked assay and study reagents,

such as standards, QC's and antibodies.

. Maintained an exemplary assay pass rate and between sample % CV.

. Responsible for detailed inventory, storage and shipment of study samples

according to client specifications.

. Collaborated as a member of a task force to identify study deviation

trends and recommend strategies for improvement.

Tufts New England Medical Center, Molecular Cardiology Research Institute,

Boston, MA 2006-2007

Research Assistant II

. Investigated the signal transduction pathway of vascular smooth muscle

contraction and relaxation using immunoprecipitations, Western blots, and

biochemical protein determination assays.

University of MA Medical School, Program in Gene Function and Expression,

Worcester, MA 2001-2005

Research Associate-Laboratory Manager

. Engineered novel zinc finger transcription factor proteins to target

specific DNA sequences for gene regulation and therapy, using the

bacterial two-hybrid and one-hybrid selection system and phage display.

. Assembled DNA constructs using recombinant DNA techniques, prepared

recombinant bacterial strains, constructed randomized codon libraries,

performed library selections, screened selected clones, analyzed DNA

sequences, generated bacteriophage for selection and site directed

mutagenesis, prepared complex selection media and small to large scale

plasmid preparations, ran biochemical ?-galactocidase assays and Western

blots.

. Maintained and catalogued vector and bacterial strain stocks as well as

hundreds of experimental clones, ordered supplies, managed expense

spreadsheet, supervised regulatory compliance of hazardous substances and

safety policies.

. Presented research findings at laboratory meetings.

. Provided supervision and training for rotation students and postdoctoral

staff.

University of MA Medical School, Division of Plastic and Reconstructive

Surgery, Worcester, MA 1993-2001

Research Technician III/Laboratory Manager

. Developed and performed cell based assays, (migration, proliferation,

neutralization, collagen contraction, angiogenesis), to determine the

effect of high glucose, IL1-?, GM-CSF, and TNF-? on wound healing.

. Implemented methods to initiate primary cultures of human fibroblasts,

keratinocytes, microvascular endothelial cells and preadipocytes using

enzymatic, immunomagnetic, and density gradient separation techniques.

Maintained and cryopreserved cells lines.

. Determined the effect of a calcium alginate wound dressing on the

proliferation of fibroblasts for Dow Hickam Pharmaceuticals which

resulted in publication of findings and use of data in company

promotional materials.

. Purified RNA from wound tissue, synthesized cDNA by RT-PCR, and purified

the product using gel electrophoresis.

. Wrote Animal and Human Subjects protocols for IRB/IACUUC approval,

ordered supplies, ensured safety compliance, maintained equipment.

. Trained and assisted surgical residents and students with research

projects.

ROBIN M. SMITH ? cell: 774-***-****? home: 508-***-**** ? E-mail:

*********@*****.***

Biogen, Inc., Process Development Group, Cambridge, MA

1993

Process Associate-contract

. Executed pilot fermentation studies in shake flasks and bioreactors to

optimize media for the production of recombinant protein therapeutics in

bacteria. Screened for protein expression by SDS-PAGE and Western blot.

Quinsigamond Community College, Worcester, MA

Technical Assistant, part time

1993

Chemistry Tutor, part time

1992-1993

Collaborative Biomedical Products, Bedford, MA

1992

Quality Control Scientist III

University of Massachusetts Medical School, Worcester, MA

Research Technician III, Department of Medicine, Oncology,

1990-1991

Research Technician III, Department of Medicine, Pulmonary

1985-1990

Tufts New England Veterinary School, North Grafton, MA

1983-1985

Research Technician

Shriner's Burn Institute, Boston MA

1982-1983

Research Technician

EG+G Mason Research, Worcester, MA

1979-1982

Laboratory Technician

EDUCATION:

M.S. Biology

Worcester State College

B.S. Animal Science

University of Massachusetts

HONORS:

Member of the Beta Beta Beta Biological Honor Society

ROBIN M. SMITH ? cell: 774-***-****? home: 508-***-****? E-mail:

*********@*****.***

PUBLICATIONS:

Xiangdong Meng, Robin M. Smith, Astrid N. Giesecke, J. Keith Joung, and

Scot A. Wolfe. "A counter-selectable marker for bacterial-based interaction

trap systems." Biotechniques. 2006 Feb;40(2):179-184

Doyle JW, Smith RM, Roth TP. "The effect of hyperglycemia and insulin on

the replication of cultured human microvascular endothelial cells." Horm

Metab Res 29:43-45, 1997.

Doyle JW, Roth TP, Smith RM, Li Y-Q, Dunn RM. "The effect of calcium

alginate on cellular wound healing processes modeled in vitro." J Biomed

Mat Res 32: 561-568, 1996.

MEETING ABSTRACTS:

Doyle JW, Smith RM, Roth TP, Dunn RM, Lawrence WT. "Wounding of cultured

human epidermal cells induces the signaling pathway for IL-1 but not for

TNF-alpha," presented at the Wound Healing Society Eighth Annual Meeting,

Salt Lake City, UT, June 20, 1998.

Doyle JW, Smith RM, Roth TP, Dunn RM, Lawrence WT. "Interleukin-1 alpha and

its type 1 receptor are induced in human epidermal cells by wounding,"

presented at the Plastic Surgery Research Council Meeting, Loma Linda, CA,

April 6, 1998.

Doyle JW, Smith RM, Roth TP, Lawrence WT. "Glucose inhibits wound

contraction modeled in vitro," presented at the 1997 Plastic Surgery

Research Council Meeting, Galveston, TX, February 27, 1997.

Smith RM, Doyle JW, Roth TP, Li Y-Q, Dunn RM, Lawrence WT. "Glucose

inhibition of microvascular endothelial cell proliferation is enhanced by

insulin," Wound Healing Society Sixth Annual Meeting, Boston, MA, 1996.

Doyle JW, Smith RM, Roth TP, Dunn RM, Lawrence WT. "Glucose directly

inhibits the contraction of fibroblast populated collagen lattices." Wound

Healing Society Sixth Annual Meeting, Boston, MA, 1996

Doyle JW, Roth TP, Smith RM, Li Y-Q, Dunn RM. "The effect of calcium

alginate on cellular wound healing processes modeled in vitro." Presented

at the Symposium on Advanced Wound Care and Medical Research Forum on Wound

Repair, San Diego, CA, May 1, 1995.

R.G. Barbers, M.D., F.C.C.P., R.Smith, L.Campbell, R.Ignotz, PhD,

D.P.Tashkin. "Transforming growth factor beta in bronchoalveolar lavage

(BAL) Fluid obtained from non-smokers and tobacco smokers." Am.Rev.Res.Dis,

1990; 141.

R.G. Barbers, M.D., F.C.C.P., R. Smith, R. Ignotz, PhD. "Transforming

growth factor beta is present in broncholaveolar lavage fluid (BALF) and

released by alveolar macrophages (AMS)." Chest. 1989; 315.

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