R&D Scientist/Chemist/ Research Associate Resume
|Desired Industry: Biotech
|Desired Job Location: San Jose, California
||Date Posted: 9/9/2009
|Type of Position: Full-Time Permanent
||Availability Date: 9/10/09
|Desired Wage: Negociable
||U.S. Work Authorization: Yes
|Job Level: Experienced with over 2 years experience
||Willing to Travel: Yes, Less Than 25%
|Highest Degree Attained: Masters
||Willing to Relocate: No
CAREER SUMMARY AND OBJECTIVE
Scientist with project level responsibilities in Research and Development for Medical and Biotechnology industries. Extensive experience as individual contributor in the areas of medical device drug coating R&D, project management and supervision involving transfer of Research and Development drug/polymer processes into manufacturing for high volume production.
R&D Scientist, Research and Development
2005 - August 2009 CardioMind Sunnyvale, CA
· Responsible for all aspects of development, loading, design, and testing of drug-coated stents for treatment of coronary artery disease; coordinating activities with 2 outside vendors (drug and polymer coating) as well as internal efforts within R&D. Responsible for the development, design, and identification of appropriate methods for Cardiomind’s drug eluting stent (DES) program in accordance with FDA regulations.
· Supported development of the drug eluting stent (DES) program and led evaluation of alternate carriers/polymers (durable and biodegradable), alternative drugs and other drug delivery mechanisms.
· Managed drug coating characterization test method development by outside test laboratory and possible method transfer to other laboratory or to Cardiomind.
· Responsible for coordinating and analyzing drug release and polymer integrity data including preparation of DES stents for subsequent animal chronic studies.
· Oversaw clinical DES coating runs for CARE II clinical trial, including stent and coating characterization, conducting shelf life tests and examination of processes to extend DES shelf life (working with coater vendor), including impact of radiation sterilization on drug content and polymer stability and use of stabilizers and other processing enhancements
· Provided analytical chemistry support for various polymers used in the CardioMind Sparrow Delivery system like HPLC, FTIR, SEM, XRF and DSC.
· 2006- 2009: Additional responsibility of providing QC/QA support for Pilot manufacturing. Provided review of stent documentation, inspection, of both DES and bare metal stents builds, as well as pilot clinical builds. including the radiopaque coating process used in the Sparrow Stent.
· Supported CardioMind’s ISO 13485 certification and recertification efforts with internal audit review of Quality System.
· Carried out feasibility study to transfer all analytical processes and testing necessary to conduct drug release verification in house. Additionally, evaluated cost/benefit of bringing analytical chemistry test capabilities in house.
Senior Scientist, Research and Development
2002 - 2005
Vascular Architects San Jose, CA
· In charge of all aspect of process development, loading and testing drug loaded stent
· Responsible for management of all projects in drug delivery program
· Contact with vendors and laboratories for testing drug-loading stent.
· Responsible for set up and testing of drug release in vitro
· Product development leader for Vascular Architects Technology: Responsible for development of new product. Qualification of process equipment for controlled release of drug, selection of supplier and vendors.
· Led a research team to develop prototype stent coating configurations/formulations for controlled release of drugs to minimize restenosis. Delivered a prototype formulation of drug loading stent to meet animal model end points. This prototype was successfully transferred to product development and became the basis for Vascular Architects products.
· Coordinated input from internal and external experts to develop technology concepts for successful transfer from research to product development.
· Evaluate cost/benefit of bringing analytical chemistry test capabilities in house.
1997 - 2002 Quanam Medical Devices (Boston Scientific) Santa Clara, CA
Senior Scientist, Research and Development
· In charge of all aspects of development, loading, design, and testing of drug-coated stents to reduce restenosis, in patients with coronary artery disease.
· Responsible for all phases of the development, design, and methods to conduct bioanalytical research on compound, drug agents, and metabolites of coronary drug delivery stent to treat restenosis in accordance with FDA regulations.
· Inventor of number of patents related to process methods, drug loaded polymeric material, incorporation of drug into a polymer component of stents, and method of manufacture.
· In house testing using and qualifying different type of catheters after complete QA and inspection for in vitro and in vivo stent testing.
· Perform drug loading, pre-testing, final test, protocol and documentation to support international-European and domestic submission of new drug-coated stents and clinical trials.
· Selection and screening of different types of drug to apply on drug-coated stents.
· Manage and coordinate number of internal projects related to polymer compatibility, drug release, QA, and manufacturing issues. Also, established relationship with analytical laboratories to address release studies on drug and polymer.
1994 - 1997 Advanced Cardiovascular System Santa Clara, CA
Scientist, Research and Development
· In charge of drug control release of various polymers using Paddle method and dissolution apparatus.
· Responsible for polymer film development and prototype for medical devices including study of structural and physical properties, cross-linking, composition, solubility, toxicity, and tissues compatibility.
· Perform polymer film analysis to optimize adhesion on metal stents. Method development of gold plating and impurities analysis using ICP 2.5. including XRF for measurement metal thickness of stent. Created documents such as MPI, SEM and protocols.
· Develop thin elastomeric films of polymers and make recommendations regarding test method protocol for polymer device formulation.
1991 - 1994
Syntex Corporation Palo Alto, CA
Chemist, Analytical Research and Development
· Quantitative analysis of biological medium for therapeutic drugs and metabolites using different HPLC methods and instruments.
· Carried out and improved development and application of different methods for the purpose of isolating and quantifying drugs and their metabolites from biological matrixes to support clinical, toxicological, pharmacokinetics, and drugs evaluation progress.
· Hand-on experience with analytic techniques and process development to ensure product compliance with current SOPs restrictions and regulations.
· Interfaced with vendors and equipment suppliers. Other responsibilities include daily instrument calibration and preparation, monitoring quality control, and general instrument maintenance.
1989 - 1991
Acurex Corporation Mountain View, CA
Scientist, Analytical Department
· Performed chemical and physical analysis of varied substances such as soil, water, and oils.
· Operated and evaluated laboratory instrumentation for Ion-Chromatography, HPLC, AA, IR, Spectrophotometer; including water and soil analysis.
· Extensive chemistry laboratory experience using turbidometric, calorimetric, titrimetric, extraction, and general analytical methods and procedures.
· Created reports and graphics for presentation.
1989 - 1992 San Jose State University San Jose, CA
Professor Assistant (P/T)
· Experience in High Temperature Superconductivity doing research and development of methods to create a superconductor crystal. Analysis and evaluation of superconductor materials.
· Support student on superconductor topics and thesis.
San Jose State University, San Jose CA
M.S. Physical Chemistry, 1997
University of Chile, Chile
B.S. Analytical Chemistry, 1986
University of Concepcion, Chile
Chemistry and Pharmacy three years of under graduate classes, 1982
Additional Course: X-Ray diffraction and Fluorescence – San Jose State University 1990.
Ion-Chromatography, Dionex 1990. HPLC- HP 1991. Velum-ACS 1996 ACS. Mathematical and Statistical sciences-The institute for professional education 1996.
Inventor and co-inventor of a number of patents and pending patents in drug delivery into polymer, drug loaded polymeric material and methods for example 7374570, 7115691, 6,653,426; 6,530,950, 6168619, EP1874373, EP1143968 and EP1150670
Available upon request.
Candidate Contact Information:
|JobSpider.com has chosen not to make contact information available on this page.
Click "Contact Candidate" to send this candidate a response.