Raymond Chan, Ph.D.

REDWOOD CITY, CA ***** acthac@r.postjobfree.com

408-***-**** www.linkedin.com/pub/ray-chan/7/bb9/338

Executive Summary

Served as Director of Operations and Director of Research and Development, driving the realization of multiple innovative FDA approved microbiological diagnostic medical device products.

• High level of expertise in planning, project management, assay development, clinical study design and management, microbiology, protein purification, quality and manufacturing process control with departmental budget responsibility.

• Set-up from scratch a GMP and ISO 13485 compliant manufacturing and quality operation.

• Implemented the SAP enterprise resource planning system and the Master Control quality documentation system.

• Coordinated transfer, validation and manufacturing activities with five different domestic and international contract manufacturers.

• Set-up and managed a Thermo Fisher facility in Sunnyvale, CA with the responsibility of overseeing the technical staff, the physical plant, interfacing with outside agencies and implementing Environmental Health and Safety programs.

• Trained as a Process Champion in corporate Practical Process Improvement (analogous to Six Sigma) and Lean Manufacturing initiatives.

Looking for an opportunity to leverage technical expertise with managerial skills in coordinating the effective use of man- power, materials and machines to achieve company goals. Professional

Experience

DIRECTOR OF OPERATIONS, THERMO FISHER SCIENTIFIC-MICROBIOLOGY DIVISION, SUNNYVALE AND FREMONT, CA 2004-2014

• Organized, trained and managed a manufacturing group making components of the Xpect line of lateral flow diagnostic assays for infectious diseases, a multi-million dollar product line for Thermo Fisher. Manufacturing included microbial culture, monoclonal and polyclonal antibody purifications, microparticle conjugations, reagent preparation, labeling and bottling.

• Established a new Quality System and oversaw its implementation in documentation, design control, complaint handling, non-conformances, validation of process improvements and the maintenance of product quality standards. Authored numerous technical protocols, quality documents, and reports.

• Coordinated transfer and managed assembly and packaging of final cassette devices with several contract manufacturers. Managed antibody manufacturing contracts with vendors.

• Streamlined and scaled-up antibody and bacterial toxin purifications. Implemented automated chromatography instrumentation in protein purification and analytical processes (AKTA, HPLC).

• Managed budgets and material supply chains for a production group, including nimble adjustments to respond to sea- sonal demand surges.

DIRECTOR OF RESEARCH AND DEVELOPMENT, REMEL INC (THERMO FISHER-MICROBIOLOGY), SUNNYVALE, CA 2000-2004

• Led the R&D project teams that designed and developed the Xpect Giardia/Cryptosporidium, Flu A&B, and Clostridium difficile Toxin A/B lateral flow format diagnostic tests. This effort required the development and characterization of monoclonal and polyclonal antibodies, the identification of target antigens and the creation, scale-up, transfer and validation of new manufacturing processes such as affinity purifications. Product design options, such as plastic parts and test kit components were evaluated and selected. For two assays, a novel branched polystreptavidin capture system was implemented and patented. PCR tests implemented for product support and discrepant analysis.

• Designed and managed clinical trials at external study sites, transferred these assays into manufacturing, developed quality control methods and played a key role in securing FDA regulatory clearance for these products. Wrote package inserts and technical portions of regulatory filings for products.

PRINCIPAL SCIENTIST, GENZYME DIAGNOSTICS, SAN CARLOS, CA 1994-2000

• Led the project teams that created new products for Group A Streptococcus, infectious mononucleosis and Giardia/ Cryptosporidium. Conducted technical improvement work on a Human Chorionic Gonadotropin (pregnancy) assay.

• Organized and managed clinical trials of products. Drafted parts of the regulatory submissions (510(k) and CLIA), manufacturing and quality control protocols.

• Played a lead role in collaborative efforts with academic scientists on the Scientific Advisory Board. Additional Experience

SENIOR SCIENTIST, ORTHO DIAGNOSTIC SYSTEMS INC (JOHNSON & JOHNSON), CARPINTERIA, CA Worked on the development and technical support teams for chlamydia, gonorrhea, and herpes simplex diagnostic as- says in a microplate ELISA format. Responsible for maintaining monoclonal cell bank and infectious agent inventory.

RESEARCH ASSOCIATE, DEPT. OF MICROBIOLOGY AND IMMUNOLOGY, UNIVERSITY OF ARIZONA, TUCSON, AZ Worked on the generation of mouse monoclonal antibodies against small hapten molecules using in vitro immunization.

POSTDOCTORAL RESEARCHER, DEPT. OF MEDICAL PATHOLOGY, UNIVERSITY OF CALIFORNIA, DAVIS, CA Laboratory focus on mammary tumorigenesis from both a molecular and cell biological perspective. Developed monoclonal antibodies against cytoskeletal proteins used for immunohistochemical and immunofluorescence identification of tumors. Conducted basic research on keratin cytoskeletal protein degradation as a marker for tumor cell death. Assisted on gene sequencing project.

Education

Stanford University, Stanford, CA BS, Medical Microbiology

University of California, Berkeley, CA -- Ph.D., Microbiology

Skills

Directed company R&D projects resulting in the commercialization of six successful new products. Conducted multiple medical device clinical trials. Organized and managed a technical manufacturing team in producing complex high quality diagnostic medical device products. Negotiated and maintained successful longterm business relationships with con- tract manufacturers and external collaborators. Hired, trained and mentored employees some of whom have reciprocat- ed by staying with my work team for many years and others who have moved on to successful careers elsewhere. Strong scientific background in microbiology and immunoassay technology, including antigen and antibody purifications, microparticle conjugations and design of manufacturing processes. Inventor on two U.S. patents and serve as a reviewer for American Society for Microbiology journals. Organized and oversaw a regulatory-compliant quality control and quality documentation system. Proficient in technical writing and in the SAP enterprise resource planning software system. Implemented and trained staff on Practical Process Improvement initiatives. Conducted forward planning to coordinate work schedules and materials with demand, resulting in efficiency in a resource-limited environment. Innovative and pro-active in making technical process improvements and problem solving. Effectively managed departmental bud- gets, material supply chains and company environmental health and safety programs. Led facility renovation and reloca- tion efforts. Served as Biosafety Officer and trained staff on Bloodborne Pathogens and BSL-2 laboratory practices. Led and supported design-controlled projects across departments, companies and countries with successful and timely results.

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