Project Manager Development

ROSS J. GRIGSBY Ph.D.

**** **** ***. ** *** Brighton, M N 55112

*********@*****.*** 612-***-****

Summary of Qualifications

Focused, results-driven Scientist with over three years of experience in pre-clinical and

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clinical pharmaceutical drug delivery research.

Extensive knowledge of pharmacokinetic absorption models, formulation of peptides and

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small molecules, designing experiments and writing reports.

Proven research group leader, consistently meeting the most challenging organizational

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goals while producing high performance standards and quality results.

E xtensive experience managing and supporting projects performed at contract labs.

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Professional Experience

Nanocopoeia, St Paul, M N

Consultant 11/2012 to present

1. Developed project proposal for testing permeability of drug nanoparticle

formulations using i n vitro and animal absorption models.

2. Identified, evaluated and managed contract labs for preclinical studies.

3. Set-up cell culture lab for cell-based permeation assays.

C ima Labs, Brooklyn Par k, M N

Consultant 8/2012 to

12/2012

Scientist I 2008

t o 1/2012

4. Instrumental in pre-clinical development through Phase I clinical t r ial for

small molecules and peptides.

1. Tested formulations in pre-clinical models and identified optimal prototype

for evaluation in human.

2. Participated in the development of a clinical protocol (Phase I) for a small

t herapeutic peptide.

3. Identified, evaluated, and managed contract research organizations for

L C/MS analysis of a peptide in Phase I t r ial.

4. Coordinated study sample shipment, review of data, and dissemination of

results.

5. Served as project manager to generate experimental results in support of

patent li tigation.

1. Led internal formulations personnel for manufacturing of test article.

2. Managed contract labs (animal research lab and bioanalytical lab) under a

very tight deadline.

6. Led challenging immunoassay development projects internally and with CROs

(ELISA, MSD, Gyros).

Ross J. Grigsby

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7. In charge of all aspects of drug delivery research and pre-clinical development.

1. Generated protocols for cell culture drug permeability experiments and

animal absorption studies.

2. Trained and directed research assistants.

3. Analyzed and presented experimental results.

8. Developed cell culture permeability and animal absorption models used for

p harmacokinetic absorption studies of peptides and small molecules, specializing in oral

t ransmucosal buccal delivery.

9. Oversaw every aspect of preclinical animal studies performed at a contract lab

for testing bioavailability of peptides and small molecules using oral, buccal, and enteric

coated formulations.

1. Formulated test articles for studies.

2. Wrote protocols for and directly supervised animal testing.

3. Coordinated sample analysis with internal analytical labs and CROs.

10. Performed pre-clinical and clinical GMP manufacturing and packaging of test

a rticles.

11. Proposed and defended the laboratory budget, secured bids and contracts,

i ni tiated and reviewed confidentiality disclosure agreements, responsible for on time

delivery of supplies and equipment.

ROSS J. GRIGSBY Ph.D.

Rensselaer Polytechnic I nstitute, T roy, NY

2006-2007

Postdoctoral Research Associate

1. Using i n vitro assays and mammalian cell assays, I successfully identified

and characterized a novel drug that targets the centrosome and inhibits

cell division.

2. Proficient in numerous laboratory techniques including protein

p urification using BioRad Biologic DuoFlow FPLC, protein purification

using sucrose density ult racentr ifugation and numerous other t raditional

and modern protein purification methods, and immunofluorescent

l abeling.

University of Kansas, Law rence, KS Degree completed

M ay 2006

Graduate Research Assistant

3. Successfully identified novel centrosome proteins from Spisula

solidissima oocytes using t radition biochemical purification techniques

combined with mass spectrometry.

Ross J. Grigsby

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4. Researched signaling mechanisms in cultured adipocytes pertaining to

T ype 2 diabetes and showed a parallel pathway for TNF signaling in

adipocytes.

5. Acquired skills in mammalian and insect t issue culture procedures, SDS-

PAGE, gel staining, immunoblotting, lipid analysis through radioisotope

l abeling, G-protein column chromatography purification of monoclonal

antibodies, brightfield, polarized light, and epifluorescence microscopy.

6. Excellent presentation skills acquired through teaching undergraduate

l aboratory classes and presenting scientific results at lab meetings and

yearly conferences.

Education

• University of Kansas, Lawrence, Kansas, Ph.D., Biochemistry and Biophysics

• Iowa State University, Ames, Iowa, B.S. Physical Education, Sports Medicine

E mphases

Honors

7. Graduate Training Grant Recipient, Dynamic Aspects of Chemical

B iology, University of Kansas, supported by the National Institute of

General Medical Sciences, T32 GM08545

8. Recipient of the Kenneth B. Armitage Award for Excellence in Teaching

P rinciples of Biology Laboratory

Publications

9. Dissertation: Grigsby, R. J. Identifying gamma-tubulin r ing complex

adaptor proteins in centrosomes isolated from the surf clam, Spisula

solidissima . University of Kansas Libraries. 2006, 154 p.

10. Grigsby, R. J., Dobrowsky, R.T. Inhibition of ceramide production reverses

T NF induced insulin resistance. B iochem Biophys Res Commun . 2001 Oct

12;287(5):1121-4.

11. Bilderback T.R., Grigsby R. J., Dobrowsky, R.T. Association of p75(NTR)

w ith caveolin and localization of neurotrophin-induced sphingomyelin

hydrolysis to caveolae. J B iol Chem. 1997 Apr 18;272(16):10922-7.

Professional Affiliations

12. American Association of Pharmaceutical Scientists

Computer Skills

13. M icrosoft Word, M icrosoft Excel, M icrosoft Power Point, Metamorph,

E ndnote, SigmaPlot, Adobe Photoshop

Ross J. Grigsby

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