Project Manager Assistant

Fuad M. Odeh, Ph. D.

Baton Rouge, LA *****, USA

225-***-****; *********@*******.***

SUMMARY OF QUALIFICATIONS

. Advanced experience in protein quantification, detection, and chemistry

and great knowledge in bioanalytical assays development, validation (ICH

guidelines), and technology transfer (ELISA, WB, UV spec, bacterial host

cell protein analysis, quantitative proteomics (HPLC, Capillary

electrophoresis), immunohistochemistry, lateral flow membrane (strip-

test), dot-blot microarray, In vitro cell based assay, formulation,

lyophilization, protein potency and efficacy, quality control

requirements (ICH guidelines), final product stability/recovery, ligand-

binding assays, and receptor-binding assays)).

. The ability to design experiments and to troubleshoot experiments that do

not yield the expected results. Well-qualified and technically-proficient

Research Scientist with more than 15 years of laboratory experience and

strong academic qualifications.

. Project Manager, knowledgeable, proven abilities to take a project on

from conception and see it through to completion. Great understanding on

how to manage both personnel and operations in an efficient and

productive way. Mentorship, knowledge sharing, and training are extremely

important to my managerial philosophy and drive my approach to

leadership.

. Organized, take-charge professional with exceptional follow-through

abilities and detail-orientation; able to plan and oversee projects from

concept to successful conclusion.

. Analytical problem solver; proven expertise in assembling and organizing

data. Demonstrated creative thinker, ability to see the "big picture"

with ability to synthesize and communicate strategies for delivering on

company goals.

EXPERIENCE

. Principal Scientist/Scientific Team Leader. TransGenRx Inc., March, 2012

to June, 2013; Baton Rouge LA, USA

Duties:

- Design activities and experiments, together with colleagues in the

other involved disciplines, to meet the top-level objectives

- Make sure the activities leading to the high-level team objectives

make scientific sense and are efficient uses of resources

- Make sure all helpful scientific input from the team is brought out

and that any differences of opinion are discussed in a logical fashion

- Assess work volume.

- Reviews 6-month budget for assigned areas of responsibility in

Laboratory.

- Make full use of the brainpower in the team!

- Elaborate pros and cons of alternative approaches during discussions

in the teams

- Recruit experts outside the project team to help solve issues

- Discuss controversial approaches with team mentors if necessary in

order to decide on the path forward.

- Commits to maintaining cGMP compliance of team activities and ensures

safety of all team members by enforcing compliance with programs

regarding health, safety and protection of environment.

- Keep the project manager in the loop at all times

- Review the objectives for clarity and completeness.

- Discuss work packages and assign team members as an ownership for

driving each defined work package.

- Ensures compliance with all Company policies and standard operation

procedures.

- Provide direction, guidance, and leadership on non-clinical program

strategy, planning statistical design of clinical trials, and applying

statistical methodology to provide information for clinical research

and statistical analyses in project teams and in interactions with

clients.

- Discuss potential challenges to the defined timelines and consider

ways to proactively deal with them.

- Discuss the resources available to address each work package and

whether some resources need to be shifted to get the job done on time.

- Document the status of the different work packages

- Involve in training how to program and operate automation systems and

performing an automated immunoassays.

- Final product formulation and lyophilization for topical and non-

topical applications.

- Final product analysis (endotoxin, impurities, HCP, purity,

concentration, potency, efficacy, and protein recovery and stability)

- Glycophorm analysis, silaylation analysis, neuroaminidase, sialidase,

glycosidase analysis using CE, HPLC, and cIEF.

- Direct involvement in development and screening on ELISA immunoassays

for monoclonal antibodies, hGH, BMP2, HDL, EPO, IFN beta, IFN alpha

2b, TSH, transposase, bacterial host cell proteins, hemoglobin, CSF,

FGF2, ovalbumin, biotin, ovomucin, BSA, chicken APOA1, and VEGF.

- Cellular-based Biomarkers analysis for BMP2-treated cell lines by

ligand binding assays (ELISA, immunohistochemistry, strip test,

Allergens detection, and WB) and biochemical activity.

- Cellular-based Biomarkers analysis for EPO-treated cell lines by

ligand binding assays (ELISA, immunohistochemistry, and WB) and cell

proliferation assay.

- Formulation studies on FGF2 topical applications.

- Prepare the statistical methods and results sections for Cell Based

Assay (Potency, ED50, and EC50) reports and overall summaries; this

responsibility includes review of protocols for soundness of trial

design.

. Principal Scientist/Director of Protein Detection and Characterization.

(TransGenRx Inc.), August, 2009 to March, 2012; Baton Rouge LA, USA

Duties

- Evaluates the performance Develops criteria and selection process for

lab testing and staffing.

- Biomarkers analysis for EPO-treated cell lines.

- Development ELISA immunoassays for monoclonal antibodies, Psa, plyG,

hGH, BMP2, HDL, EPO, IFN beta, IFN alpha 2b, TSH, transposase,

hemoglobin, CSF, FGF2, ovalbumin, BSA, chicken APOA1, and VEGF.

- Provides expert advice in sampling configurations, experimental

design, and analytical methods

- Development strip test for E. Coli host cell proteins (HCPs).

- Involve in EPO, hGH, BMP-2 and FGF2 formulation studies and protein

recovery/stability studies.

- Train part time employees, research associate, and research assistant

in operating, calibrating and maintaining Beckman Coulter instruments

(liquid handlers) such as Biomek2000, Biomek FX, centrifuges,

Multimek, PA800, PF2D, and SAMI Sagian ORCA NT technology.

- Protein analysis and quantification using CE, IEF, and HPLC.

- Biostatistics and Data analysis, interpretation, and documentation

(Excel, SAS program, Logistic models, multiple regressions).

- Make recommendations for operational and/or technical improvement

- Leader who can function independently and navigate ambiguity

- Train and supervise staff members, clients, and part time employees

(students) in routine and specialized proteomic analytical techniques.

- Write, design, qualify, and validate standard operation procedures in

the area of analytical chemistry and proteomics.

- Experience with automated immunoassays, sample management systems

. Assistant Professor/Biotechnology/proteomic Research. Louisiana State

University, Dept. of Veterinary Sciences, Baton Rouge, LA, USA, Oct.,

2008 to August, 2012.

Duties

- Involve in protein formulation for proteins hGH, EPO, BMP2, and FGF2.

- Responsible for the design, development, and implementation of

scientific research projects.

- Immunoassay development, validation, troubleshooting, and technology

transfer.

- Involve using a variety of data analytic methods to solve real life

predictive analytics problems

- Work with team members in QA to ensure adequate SOP's are created and

implemented within the biostatistics, and data management functional

areas.

- Assist in establishing, developing, and/or optimizing bioanalytical

methodology to test purity, potency, efficacy, and the identity and

concentration of impurities

- Study, identify and characterize animals protein chemistry and

genomics

- Cell culture and formulation reagents.

- Evaluate and adapt new techniques and methodologies emerging from

academia and industry.

- Supervise in laboratory management and administration.

- Ensure functional protein detection laboratory, calibrate, and

maintain proteomic instrumentation periodically.

- Providing analytical methods manufacturing support and troubleshooting

of late-phase development products.

- Mentoring a group of analytical development staff.

. Post-doctorate Researcher. Data analysis, biochemistry, and protein

chemistry analysis. Louisiana State University, Dept. of Veterinary

Sciences, Baton Rouge, LA, USA, Aug., 2003 to Nov. 2009.

Duties

- Train part time employees, research associate, and research assistant

in operating, calibrating and maintaining Beckman Coulter

instruments such as Biomek2000, Spec280, Biomek FX, centrifuges,

PA800, PF2D, and SAMI Sagian ORCA NT technology.

- Responsible for the design, development, and implementation of

scientific research projects.

- Mentoring a group of analytical development staff.

- Writing SOPs for ELISA, WB, PCR, HPLC, Protein and DNA isolation, DNA

sequence, Strip test, cell based assay...etc.

- Study, identify and characterize protein chemistry and genomics

- Host cell protein analysis.

- Cell culture and formulation reagents.

- Evaluate and adapt new techniques and methodologies emerging from

academia and industry.

- Supervise in laboratory management and administration.

- Ensure functional protein detection laboratory, calibrate, and

maintain proteomic instrumentation periodically.

- Providing analytical methods manufacturing support and troubleshooting

of late-phase development products.

. Research Associate specialist-quail breeding manager- Applied Animal

Biotechnology Laboratory. Louisiana State University, Dept. of Animal,

Dairy, and Poultry Sciences, Baton Rouge, LA, USA, Jan., 2002 to Aug.,

2003.

Duties:

- Involve in immunogenicity, vaccine, and environmental responsiveness

studies, Biotechnology tools for farm animals.

- Quail breeding strategy and management.

- ELISA, WB, SDS-PAGE, RIA

- Laboratory Management.

. Graduate Research Assistant. Louisiana State University, Dept. of Animal,

Dairy, and Poultry Sciences, Baton Rouge, LA, USA, Jan., 1999 to Aug.,

2002.

. Research and Teaching Assistant. Food chemistry analysis, Diet

formulation and Breeding. Dept. of Animal Production, Jordan University

of Science & Technology, Irbid, Jordan, March 1997 to Dec. 1998.

REFERENCE PERSONS:

1) Dr. Michael S. Crapanzano, MD Pediatric Cardiology, Board Certified

7777 Hennessy Blvd Suite 103

Baton Rouge, LA 70808

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

2) David G. Spencer, Ph.D. CEO

Biotechnology Enterprise Management, LLC

8820 Galax Ct.

Chapel Hill, NC 27516

USA

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

3) Tee Bordelon, Ph.D. Associate Scientific Director/ TransGenRx Inc

Louisiana Emerging Technology Center

Baton Rouge, LA 70803

Tel. 225-***-****

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

3) Billy F. Dudley, Ph.D. Director of Optimization and

Manufactoring

TransGenRx Inc.

Louisiana Emerging Technology Center

Baton Rouge, LA 70803

Tel. 225-***-****

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

EDUCATION

Educational institution Area of study Degree Grad year

LOUISIANA STATE UNIVERSITY, ANIMAL DOCTORATE 2003

BATON ROUGE SCIENCES/Quantita

tive Genetics

LOUISIANA STATE UNIVERSITY, ANIMAL MASTERS 2001

BATON ROUGE SCIENCES/GENETICS

JORDAN UNIVERSITY OF AGRICULTURAL BACHELORS 1997

SCIENCE, AND TECHNOLOGY SCIENCES

. Ph. D. Animal, Dairy, Poultry Sciences, Louisiana State University,

Baton Rouge, LA; Animal Science with concentration on Animal Breeding,

population genetics, and biotechnology).

. M. S., Animal, Dairy, Poultry Sciences, Louisiana State University, Baton

Rouge, LA; Animal Sciences with concentration in Animal Genetics and

molecular biology.

. B.Sc., Agricultural Sciences; Animal Production, Jordan University of

Science and Technology, Irbid, Jordan;

Technical Skills

Genomics: gene expression, RFLP, AFLP, and Micro-satellite Marker PCR, RT-

PCR, RNA micro-chips, gel electrophoresis, autoradiography, DNA sequence,

QTL analysis, cell culture, transfection reagents.

Proteomics: ELISA, Dot blot, Western blot, SDS-PAGE, ligand binding

assay, protein micro-array, HPLC, Ion Exchange Chromatography, Biological

activity (cell-based assay), strip test assay, immunohistochemistry, cell

extraction and protein isolation, total protein assays, 2D chromatography,

affinity chromatography, size-exclusion (SEC), ion exchange chromatography,

carbohydrate staining, capillary electrophoresis, Isoelectrical focusing,

Zinc precipitation, Ammonium sulfate precipitation, host cell protein

analysis, protein and food chemistry analysis.

Bioinformatics: Marcov chain models, blast, arlequine, mega, PAUB.

Prediction simulation softwares, Amino acid sequence alignment, nucleotide

sequence alignment, protein secondary structure predictions, post-

translational predictions.

Quantitative and population Genetics: Advanced linear regression, multiple

regression models, ANOVA, ANCOVA, Four-parameter Logistic model,

Quantitative genetics and animal breeding, Heritability, gene effects, and

repeatability estimations, MTDFREML prediction of genetic parameters, REML,

BLUP estimated breeding values, selection and mating strategies, QTL

analysis. Development of breeding models and statistical design. Finding

genes responsible in stress responsiveness in birds, and detecting genetic

polymorphism in Animal related to production trait in steers.

Statistical skills: Parameter logistics models, multiple regressions,

linear regression, polynomial regression, log models and transformation

analysis, mixed model analysis, ANOVA, ANCOVA, correlation coefficient, t-

test, F-test, Q-test, outlier analysis, random design, maximum likelihood

analysis, jackknifing, and bootstrapping.

Teaching skills: Teaching courses related to Biostatistics, QTL analysis,

molecular biology, feed chemistry analysis, animal breeding and genetics,

and agricultural sciences.

Article (Review) Skills: Review articles for the journal of Heredity that

were related to plant genetics, QTL analysis, DNA markers, marker assisted

selection, and stress responsiveness.

Computer skills: MS word, excel, access, power point presentation, groove,

publisher, Visio, outlook, and OneNote. Programming Languages: Fortran,

Statitiques, Statistical analysis system (SAS program).

PRESENTATION and PUBLICATIONS

1) Presentation title: "Use of AFLP DNA markers to evaluate genomic

diversity and genetic distances in Japanese quail lines divergently

selected for stress responsiveness". Joint meeting of the American Dairy

Science Association, American Meat Science Association, American Society

of Animal Science, and Poultry Science Association. July, 2001,

Indianapolis, Indiana.

2) Presentation title: "Genetic characterization of stress responsiveness

in Japanese quail". International Poultry Science Forum, Atlanta,

Georgia, Jan. 15-16, 2001.

3) Odeh, F. M., G. G. Cadd, and D. G. Satterlee, 2003. Genetic

characterization of stress responsiveness in Japanese quail. 1. Analyses

of line effects and combining abilities by diallel crosses. Poultry Sci.

82:25-30.

4) Odeh, F. M., G. G. Cadd, and D. G. Satterlee, 2003. Genetic

characterization of stress responsiveness in Japanese quail. 2. Analyses

of maternal effects, additive sex linkage effects, heterosis, and

heritability by diallel crosses. Poultry Sci. 82:31-35.

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