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Medical Device Quality Control

Location:
La Jolla, CA
Posted:
November 28, 2012

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Resume:

WILLIAM Z. KEHAYIAS, JR.

**** ****** ****** #*-***

San Diego, CA 92109

858-***-**** abgfdh@r.postjobfree.com

Employment Goal:

Associate Scientist Bioprocess Development

Protein Purification, R&D

EMPLOYMENT HISTORY:

Apr. 2012-Sept. 2012

Lab Support On Assignment

Celgene, Inc.

Responsible for purifying crystallography grade proteins as therapeutic

drug candidates to elucidate new variable site structures of rE.coli

expressed constructs. Successfully purified drug candidates achieving

increased yield, purity and optimal apo-crystal formation, later complexed

with IMIDs (crystallization achieved). Work included transformation,

expression trials, mid-scale fermentation, purification process

optimization and protein delivery. Analytical efforts required total

protein, SDS-PAGE, Western Blot and Qualitative TOC Mass Spec HPLC.

Jun. 2010-Aug. 2021

NEXBIO, INC.

Senior Research Associate, Drug Substance Development

Performed experiments for optimization of downstream processing for an rE.

Coli expressed protein therapeutic to finalize the phase three drug

substance purification process. Efforts included IEX, HIC and RP

chromatography unit step finalization by optimizing binding capacity, HCP

removal, endotoxin removal, column cleaning, column size and flow

parameters. Studies to improve initial recovery, clarification by

continuous-flow centrifugation and UF/DF unit operations were conducted.

AKTA and Bio-Rad FPLC, analytical HPLC and SDS-PAGE analysis were routinely

utilized. Responsibilities included planning, design and execution of

experiments. Study reports and protocols were authored and included in

master reports to satisfy NIH contracts. Studies assisted scale-up and

technical transfer to CMO's.

June 1998-Jan 2009

EMD Biosciences (Calbiochem)

Associate Scientist, Biochemical Manufacturing Development

Protein Production and Process Development

*Performed purification of proteins, developing processes from the

literature and early protocols. *Purified enzymes in mg to gram quantities

from various plant, animal, microbial and recombinant microbial sources;

optimized small molecule purification from algal sources

*Fermentation, plasmid isolation, transformation and expression

optimization, preparative HPLC, IEX, HIC, affinity and gel-filtration

chromatography

*Intensive process development was required. Responsible for training

incoming scientists in the large-scale fine purification of proteins by

supervising several initial projects assigned to them

Apr. 1997- May 1998

Pacific Pharmaceuticals, San Diego CA

QC/QA/Manufacturing Associate

*Planned and completed manufacturing validations and reports for a newly

approved

Class II medical device (diagnostic test kit). Was the sole QC/QA/Mfg.

personnel, post-approvable letter

*Wrote PMA supplements to the FDA for final labeling, IFU and shelf-life

studies

*Originated QC/QA documents and performed tech transfer to turn-key

manufacturers

Aug. 1994-Mar. 1997

Protein Polymer Technologies, Inc., San Diego, CA

Research Associate, Bioprocessing

*Developed rE.Coli fermentation and downstream purification efforts to

bring a medical device to market in collaboration with Johnson and

Johnson

*Achieved greatly improved yields in existing large-scale processes using

carefully applied

technique and industry methods; eliminated problematic cytotoxin from

the process

Dec. 1989-Jul. 1994

Clonetics Corporation, San Diego, CA

Supervisor of Manufacturing; Quality Control Technician

*Supervised a production laboratory manufacturing complex media and growth

factors intended

for the growth of normal human cells

*Cell culture and Q.C. of normal human cell types and growth systems

*Conducted in-house GMP training sessions on documentation and laboratory

practices

Aug.1983-Oct. 1989

SmithKline-Beckman Microbics,Carlsbad, CA.

Fine Enzyme Purification Technician II

*Performed all analytical, laboratory and production plant tasks associated

with the fine

purification of bulk enzymes manufactured for use as diagnostic reagents

*Large-scale facility required cross-training on a 12,000L fermentation

tower and

downstream recovery area in all areas of industrial fermentation

*Large-scale gel-chromatography, filtration, hollow fiber concentration,

continuous flow

centrifugation

Professional Courses:

ISO 9001 Certified Internal Auditor

Millipore Seminar on Industrial Validation and Integrity Testing

Raymon Wong HPLC Method Development Seminar

Applied Immunology UCSD Extension

SAP Inventory User

Professional references available upon request.



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