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Scientist/ Regulatory Affairs Specialist

Location:
Houston, TX, 77054
Salary:
60,000/yr
Posted:
November 29, 2011

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Resume:

OBJECTIVE

To obtain an entry level position in Regulatory affairs that will utilize my academic and pharmaceutical industry knowledge of biological products to aid in product life cycle management and gain hands-on experience in ensuring that biological products brought to market adhere to all FDA regulations.

EDUCATION

Pharmacovigilance and Drug Safety Training (September 2011 – November 2011)

Ph. D. Bioengineering, Rice University (2005-2011)

B.S. Electrical Engineering - Magna Cum Laude, California State University, Sacramento (2000-2004)

WORK EXPERIENCE

Postdoctoral Research Technician (August 2011 – November 2011) Rice University, Department of Bioengineering.

Developed a method for quantal amplification of biomarker signals on fixed cells. The targeting agents were based upon antibodies covalently-linked with oligonucleotides, and utilized sequence specificity to selectively amplify fluorophores on proteins of interest.

Graduate Student (2005 – 2011) Rice University, Department of Bioengineering. Graduate Advisor: Michael Diehl

Thesis project focused on the development of a new imaging probe technology using specifically designed oligonucleotide complexes that allows fluorescent signals on fixed cells to be erased efficiently from a sample.

Ph.D. Thesis: Multiplexed and Reiterative Detection of Protein Markers in Cells using Dynamic Nucleic Acid Complexes

Graduate Intern: Nucleic Acids Delivery Methodologies (2010 summer) Life Technologies, Carlsbad California.

Assessed pathways involved in endocytosis of diverse cationic lipids via inhibitor assays and fluorescence colocalization studies in primary and immortalized cell lines.

Teaching Assistant (August 2006 – Dec 2007) Rice University, Department of Bioengineering.

Senior Design –Served as a resource for global health related design projects and electronics/electrical circuit design projects by providing scientific and technical information to assist students in their project implantation. Graded homework and coached students on power point presentation organization, content and style.

SKILLS

Regulatory Skills: Knowledge of IND, NDA/BLA in CTD format, Global Regulatory Submissions, CFR, FDA and ICH Guidelines. Preparing for Regulatory Affairs Certification Exam.

Laboratory Skills: Proficient in molecular biology techniques, microscopy, analytical techniques and use of laboratory instruments (FACs, FPLC, HPLC, spectrophotometer etc).

Management and Leadership Skills: Training and supervision of lab personnel, establishment of cell culture lab and management of lab resources.

Computer Skills: Matlab, Labview, Imaging software (Metamorph, NISelements), and Microsoft Office suite.

AWARDS AND ACTIVITIES

Rice University Pre-doctoral Fellowship (August 2005- May 2011)

2nd Place Institute of Electrical and Electronics Engineering (IEEE) Region 6 Design contest (March 2004)

Customer service volunteer Ten Thousand Villages (March 2010 - present)

Texas Medical Center Student Activities Board member (April 2010 – May 2011)

*A list of publications and presentations will be submitted upon request.



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