Allen Andrew

E-Mail: ygm66e@r.postjobfree.com

Professional Summary

Results-oriented operation director with over 20 years of scientific experience seeks challenging position in the Life Science industry.

Education

California State Polytechnic University Pomona, CA

M.S. Degree Biological Sciences

California State Polytechnic University Pomona, CA

B.S. Degree Microbiology

California State Polytechnic University Pomona, CA

Chemistry

Accomplishments

Project/Operation Management ??.

Cancer Diagnostics ??.

Instrument Development Manufacturing/Production ??.

Assay Design ??.

Microarray R&D PROFESSIONAL HIGHLIGHTS Implement Cytogenetic, FISH, FLOW, IHC and PCR labs Redesigned entire clinical lab to increase lab work flow Served as liaison between R&D and clinical lab regarding technical transfer activities Setup the Molecular and FISH diagnostic labs for cancer diagnostic lab in Irvine Setup a second Molecular and FISH lab for a cancer diagnostic lab in Irvine Developed critical business networks with outside research groups and vendors Generated 600K per month in sales for a cancer diagnostic lab which sold to GE Established stability testing for new clinical reagents Evaluated stability testing and lot release results Maintained clinical lab documentation/SOPs Initiated QA and QC guidelines ??.

Clinical Laboratory Technologist, State of New York License Clinical Genetic Molecular Biologist Scientist, State of California License Clinical Laboratory Specialist in Molecular Biology, NCA 2004 How to Manage Inventories and Cycle Counts, Hitachi Chemical 2004 Successful Project Management, Hitachi Chemical 2004 Supervisor Basics, Hitachi Chemical 2003 MAS90 Training, Hitachi Chemical 2003 DBA Training, Hitachi Chemical 2002 Safety Training, RoboDesign 2002 ISO 9001 Training, Management Systems International 2002 Coaching for Performance and Development, Stratagene 2000 Management Organizational Skills, Stratagene 1999 Routine/Cancer Diagnostic Laboratory, San Diego, CA Sept.

2011 ??.

Present Vice President of Lab Operations/Clinical The CLIA certified lab specializes in unique esoteric assays to diagnose disease.

These assays are enable clients to evaluate cancer, detect antibodies, monitor drug therapy, and detecting viruses and bacteria.

Recruited by CEO to implement Cytogenetic, FISH, FLOW, IHC, PCR and General Chemistry Working with QA Director to prepare clinical lab for CLIA and CAP certification Currently managing 2 directors, 3 manager and facility manager Ensure that clinical SOP documentation is maintained Worked with QA department to setup QA and QC guidelines Cancer Diagnostic Laboratory, San Diego, CA October 2010 ??.

September 2011 Senior Director of Lab Operations/Clinical The CLIA certified lab utilizes unique diagnostic assays to diagnose disease which enables doctors to treat and cure patients.

Recruited by CEO to implement Cytogenetic, FISH and FLOW Worked with QA Director to prepare clinical lab for CAP certification Managed 2 directors, 2 manager and safety/accessioning supervisor Ensured that clinical SOP documentation was maintained Genomics Laboratory, San Diego, CA October 2010 ??.

December 2011 Director, Lab Operations Consultant/Clinical Genomics Laboratory, San Diego, CA November 2009 ??.

October 2010 Director of Lab Operations/Clinical The CLIA certified genomics lab uses state-of-the-art chip technology to determine an individual???s genotype and compare it with scientifically sound genetic information.

Implemented new high through-put DNA isolation methodology Prepared clinical lab for CLIA and CAP certification Managed 3 clinical scientists and 4 associate scientists Maintained clinical SOP documentation Setup QA and QC guidelines Diagnostic Laboratory, Irvine, CA November 2007 ??.

November 2009 Laboratory Site Manager/Clinical The Clinical Lab implements cancer diagnostic testing by employing FLOW Cytometry, Cytogenetic, fluorescent in situ hybridization, DNA sequencing and quantitative RT-PCR technologies.

Redesigned entire clinical lab to increase lab work flow Brought up FLOW Cytometry and Molecular labs Served as a liaison between FL,TN and CA sites regarding technical transfer activities Worked with outside research groups and vendors to acquire validation specimens Implemented new fluorescent in situ hybridization testing Managed 14 clinical scientists and 10 lab associates Initiated stability testing for new clinical reagents Maintained clinical lab documentation/SOPs Approved lot release and stability results Developed various PCR/RT-PCR test Cancer Diagnostic Laboratory, Aliso Viejo, CA June 2004 ??.

October 2007 Molecular Oncology Supervisor/Clinical The Molecular Lab develops clinical diagnostic assays by employing fluorescent in situ hybridization, DNA sequencing and quantitative RT-PCR technologies.

Served as a liaison between R&D and clinical groups regarding technical transfer activities Worked with outside research groups and vendors to purchase validation specimens Directed stability testing and lot to lot comparisons for new clinical reagents Managed three lead scientists, 11 clinical scientists and one R&D scientist Designed and setup two Molecular labs within a one year time span Started a tissue culture lab for positive control manufacturing Launched two FISH labs within a one year time span Initiated fluorescent in situ hybridization testing Maintained clinical lab documentation/SOPs Signed off on lot release and stability results Developed various PCR/RT-PCR assays Setup QA and QC guidelines Started initial safety program Hitachi, Irvine, CA May 2002 ??.

June 2004 Process Development Manager/Manufacturing RNAture manufactures high throughput mRNA isolation products for gene expression analysis.

I was brought in to re-establish this product line after a restructuring of the manufacturing group.

Initial product was brought back online under my guidance.

Led process development and manufacturing of new products Worked with outside vendors to reduce manufacturing cost Supervised a staff of three scientists and two technicians Revised RNAture???s Standard Operating Procedures Implemented MAS90 production software to stream line manufacturing Redesigned shipping and receiving base on MAS90 software Developed Bill of Material production documents for MAS90 Directed inventory control maintenance using MAS90 Developed Cost of Goods documents for MAS90 Reduced shipping costs by replacing FedEx with DHL RoboDesign, Carlsbad, CA January 2001???- May 2002 Vice President of Life Sciences/Manufacturing Designed and marketed a novel microarray instrument with an integrated vision system linked to a patented dual head printing process.

This revolutionary design automated the printing and reprinting processing required for production of high quality microarrays.

Initiated the production, marketing, and sales campaign for the RoboArrayer Provided leadership and direction for the engineering team Analyzed current microarray instrumentation for available features Wrote software specification based off instrumentation design experience Assisted with software testing and debugging Worked with customers to determine specific functionality requirements Assisted with hardware design based on understanding of customer needs Worked closely with cross-functional teams in initial production Generated cost analysis breakdown based on materials and labor needs Led product launch of novel microarray system Managed application scientist that monitored product performance Initiated software/hardware changes based on customer feedback Produced/presented company presentations to customers and conferences Stratagene, La Jolla, CA February1998 ??.

December 2000 R&D Staff Scientist/Production Manager I was brought in to develop a proof-of-concept lab for cDNA microarray technology, specifically for research and development.

Within six months, I was promoted to the microarray production manager, and oversaw content development and array design.

Supervised a staff of five scientists Designed and built a microarray printer for the research and development facility Developed microarray research and development facility in three months Production facility operational in eight months Collaborated with outside manufacturer, Phenogenix, for cDNA production Managed molecular beacon synthesis group for custom service department Setup QA and QC guidelines for generation of cDNA and molecular beacons Initiated and designed all manufacturing SOP and QC procedures Produced pretreated slides with low uniform background Designed high efficiency Cy3???Cy5 labeling protocols Increased array production with novel microarray software Designed novel printing pins for more uniform printing Developed multi-well PCR purification kit to increase throughput UCLA, Los Angeles, CA March 1997 ??.

February 1998 Senior Research Scientist/Microarray Facility Manager The microarray facility at UCLA was not progressing at the desired level of efficiency, and it was my task to expedite its development.

I determined the microarray software was inadequate and initiated appropriate changes.

This redesign optimized the microarray speed and functionality.

Supervised a staff of two scientist Oversaw daily operations of microchip fabrication Directed software rework for microarrayer Software redesign produced a 10 fold increase in chip production Initiated and designed QC procedures Designed and tested novel printing pins Oversaw daily operations of microchip fabrication NGI, Los Angeles, CA August 1994 ??.

March 1997 Senior Scientist/R&D Metastasis or tumor cell shedding in the circulation is critical in the progression of cancer.

We believed the number of metastatic cells in the circulation was important in assessing tumor progression and potential for metastasis.

Tumors are mixture of diverse cells, therefore a multi-marker RT-PCR test was needed to take into account the varying levels of mRNA expression in this unique cell population.

Identified new cancer markers through publication searches Performed advanced BLAST search for PCR primer design Developed melanoma cancer markers into a RT-PCR assay Designed over 20 specific primer sets as markers for breast, prostate, colon, lung, glioma, melanoma and pancreatic cancer Optimized reaction conditions for all RT-PCR primer sets Xoma, Santa Monica, CA July1990 ??.

August 1994 Associate Scientist III/R&D T-cells are known to play an important roll in the development of autoimmunity.

Therefore, agents that have the capacity to knock out T-cells should result in the reduction of this cell population, thus slowing down the progression of this disease state.

Constructed cDNA plant libraries Developed immunoconjugates and immunotoxin constructs for mammalian and bacterial expression systems Designed assay for Fab-M13 expression system Optimized binding efficiency of Fab fragments to T-cell surface antigens Cloned unique plant toxins for linkage to optimized Fab fragments Cloned genomic CD5 gene for production of transgenic mice Assistant Radiation Safety Officer.

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