Development Medical Device

Angelica Alvarado 408-***-**** Home

**** ****** **** *** 408-***-**** Mobile

Gilroy, CA 95020 abmhgt@r.postjobfree.com

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,

QA/QC, validation, project management and supervision involving transfer of

Research and Development drug/polymer processes into manufacturing for

high volume production.

EXPERIENCE

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.

. Experience in cardiovascular, product development in the medical device,

analytical and biotechnology industries.

. 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.

. Conducted bench test, mechanical tests and failure mode analysis of stent

delivery 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.

. Experience in working with self expanding spiral covered PTFE stents and

PTFE stents loaded with drugs for femoral artery (SFA) occlusion.

. 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.

. Work closely with the engineer team helping design new fixtures for the

drug delivery process.

Senior Scientist, Research and Development

1997 - 2002 Quanam Medical Devices (Boston Scientific)

Santa Clara, CA

. 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.

Scientist, Research and Development

1994 - 1997 Advanced Cardiovascular System

Santa Clara, CA

. 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.

. Analysis of galvanic corrosion on stent using EG & G corrosion system

model 263.

. Performed analysis preparation and bench test of bath solution for gold

plating stent.

. Designed fixture for gold plate using Velum program. Designed and built

bench to perform gold plating.

. Experience with Instron, laser micrometer, and UV spectrophotometers.

Performed thermodynamic and thermo-fluid calculations to direct and

support engineering approach.

Chemist, Analytical Research and Development

1991 - 1994 Syntex Corporation

Palo Alto, CA

. 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.

Scientist, Analytical Department

1989 - 1991 Acurex Corporation

Mountain View, CA

. 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.

Professor Assistant (P/T)

1989 - 1992 San Jose State University

San Jose, CA

. 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.

EDUCATION

San Jose State University, San Jose CA

M.S. Physical Chemistry

University of Chile, Chile

B.S. Analytical Chemistry

University of Concepcion, Chile

Chemistry and Pharmacy three years of under graduate classes

Additional Course: X-Ray diffraction and Fluorescence - San Jose State

University 1990.

Ion-Chromatography, Dionex 1990. HPLC- HP Velum-ACS Mathematical and

Statistical sciences-The institute for professional education

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

REFERENCES: Available upon request.

Contact this candidate