Medical Device Engineer
Resume:
Edward G. Parent
**** *** ******* *** • LOS ANGELES, CA 90042
PHONE: 323-***-**** • EMAIL: ************@*****.***
PROFILE
R&D SCIENTIST WITH OVER 25 YEARS EXPERIENCE IN THE BIOTECH AND MEDICAL
DEVICE INDUSTRY. A KEY SCIENTIST AS A MEMBER OF A TEAM THAT HAS
BROUGHT SEVERAL MEDICAL DEVICES FROM INCEPTION TO EITHER CLINICAL
TRIAL OR TO MARKET. SCIENTIST THAT DEVELOPED AND PATENTED POLYMERIC
BIOMATERIALS FOR USE AS IMPLANTABLE MEDICAL DEVICES, DRUG DELIVERY
SYSTEMS, AND TOPICAL APPLICATIONS. KNOWN FOR ABILITY TO FABRICATE AND
SYNTHESIZE NEW BIOMATERIALS FOR USEFUL PURPOSES. DESIGNED AND
EXECUTED BIOCOMPATIBILITY AND EFFICACY TESTS TO QUALIFY MEDICAL
DEVICES AND COMBINATION PRODUCTS. EXPERIENCED IN BRINGING PRODUCTS
FROM BENCH TOP TO LARGE SCALE PRODUCTION WITH A WORKING KNOWLEDGE
OF FDA REQUIREMENTS, 21 CFR 820, GMP’S AND GLP’S AS WELL AS ISO 13485.
Professional experience
SEPTEMBER 2012 – PRESENT PRIVATE CONSULTING LOS ANGELES, CA
Sr Scientist.
Advise clients on methods of cross linking and biopolymer conjugation.
2011 – SEPTEMBER 2012 JOHNSON AND
JOHNSON LOS ANGELES, CA
Process Engineer - contract
Transfer technology of topical emulsions and OTC drugs and to bring these products form
bench to large scale manufacture. Optimize and streamline manufacturing processes. Work to
improve and develop formulations of emulsions using design of experiments. Conduct stability
studies including preservative challenge. Track and improve process capability of manufactured
products using Minitab. Working under GMP. Write SOP’s, Protocols, and technical reports.
Mentor junior staff.
2003 2010 HYLAMED INC / LUROMED LLC TARRYTOWN, NY
Sr. Scientist
Developed and Patented polymeric biomaterials for drug delivery, soft tissue augmentation,
ophthalmic, and medical implant based on bio polymer hydrogels.
Developed and patented surface active co polymer for topical drug delivery
EDWARD G. PARENT • 4041 VIA MARISOL 104 • LOS ANGELES, CA 90042
PHONE: H: 323-***-**** • EMAIL: ************@*****.***
C: 323-***-****
PAGE 1 OF 4
Modify biopolymers by grafting, cross linking, and conjugation.
Release batches write CoA based on micro and analytical reports.
Investigate methods for sterilization in place, and terminal sterilization.
Investigate anti microbial drug for otitis media.
Investigate preservative systems for microbial efficacy.
Investigate autoclave cycles for implantable medical device.
Investigate CAPA and NC
Develop topical skin care drug delivery systems of protein and peptides.
Developed and improve process using DOE, transferred technology to CMO.
Supervise and audit contract manufacturers, labs, and suppliers
Set up and supervised a new research lab, analytical lab, and a production facility.
Set up system of QC and QA in compliance with FDA Regulations.
Write Patents, SOP’s, Protocols, and technical reports
2000 2002 GENZYME BIOSURGERY RIDGEFIELD, NJ
Staff Scientist I (after merger with Biomatrix Inc)
Worked in large groups on several projects simultaneously to develop new drug delivery systems,
new polymeric based biomaterials, and to develop and scale up new products. Some projects I
worked on include:
Supervised Biochemistry R&D labs, including Safety and efficacy, Drug Delivery, Material
development, and Tissue Culture
Develop autoclave cycle for implantable medical device
Develop methods of sterilization including steam, chemical, and filtration
Developed polymer patch for cardiac drug delivery of anti atrial fibrillation drug.
Developed hydrogel based drug delivery system for Intraarticular drug delivery for cartilage
repair
Developed a drug delivery system for corneal wound healing
Developed coatings for polyurethane catheter.
Development of endotoxin testing for micro lab.
Develop methods of endotoxin reduction in manufacturing.
Test medical device for sterility and source of microbial contamination.
Developed scaffold for tissue engineering of heart valve
Develop delivery systems for proteins, peptides, and small drugs.
Developed prototype of a drug eluting stent coated with cross linked Hyaluronic acid
Develop and scale up new implantable arthritis device based on biomaterial
Developed and patented a HA – drug conjugate for targeted drug delivery of alpha
interferon
Troubleshoot manufacturing
EDWARD G. PARENT • 4041 VIA MARISOL 104 • LOS ANGELES, CA 90042
PHONE: H: 323-***-**** • EMAIL: ************@*****.***
C: 323-***-****
PAGE 2 OF 4
Atomic Force Microscopy
Radiation Safety Officer
1983 2000 BIOMATRIX INC Ridgefield, NJ
Scientist
Worked at a start up company with 9 other people, Biomatrix grew to a company with 500+
employees worth $750M. Worked to develop biomaterials marketed as medical products such as
® ® ®
Synvisc, Hylaform, and Hylashield .
Developed and implemented testing procedures for biocompatibility and efficacy to qualify
Hyaluronic acid based medical devices.
Viscosupplemtation for joint, soft tissue and ophthalmic use
in vitro compatibility with blood and tissue
Develop terminal sterilization methods of medical device and drugs
Immune response and ELISA development
Investigate bacterial bioluminescence methods for biocompatibility
Degradation and metabolic clearance studies.
Studied hyaluronan in bodily fluids, i.e. the vitreous and synovial fluid
Studied receptor binding, endocytosis, cell adhesion, and proliferation
Supervise technical staff
Purified and characterized enzymes, and proteins
Tissue culture and organ culture.
Write SOP’s, Protocol’s, Reports.
Developed and evaluated a platform of Drug Delivery Systems for a variety of applications.
Worked to bring products from bench to pilot plant, prepared products for clinical trial, Key scientist
that brought several products from concept to clinical trial or market including;
Synvisc(R), Hylaform(R), Hylagel(R)Uro, Hylagel(R), Hylasine(TM), Hylashield(R),
Hylagel(R)Eye, Hylagel(R) Vasc, Captique(TM).
Education
1984 1985 Graduate Center of the City University of New York NY, NY
Graduate courses in Biochemistry and Cell Biology
1978.1982 SUNY@ Old Westbury Old Westbury, New York
EDWARD G. PARENT • 4041 VIA MARISOL 104 • LOS ANGELES, CA 90042
PHONE: H: 323-***-**** • EMAIL: ************@*****.***
C: 323-***-****
PAGE 3 OF 4
BS. in Biology
EDWARD G. PARENT • 4041 VIA MARISOL 104 • LOS ANGELES, CA 90042
PHONE: H: 323-***-**** • EMAIL: ************@*****.***
C: 323-***-****
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