Microbiology Manager

Daniel Spangler

**** ***** ***** ****

Fort Worth, Texas 76126 817-***-**** (cel.)

e-mail: ***********@***.***

MICROBIOLOGIST/MANAGER: QA and R&D

Microbiologist (MS) with over 15 years RD/QA Management experience in pharmaceutical (ophthalmic, parenterals and biopharmaceuticals) industry, and ~8 years experience in Medical Device Quality Assurance/Applied Research relative with a focus on sterility assurance and infection prevention. Bi-lingual (English & Spanish).

EXPERIENCE

Alcon Research, LTD 2009-2012 Fort Worth, Texas Senior Scientist

R&D Microbiology Management position in Preservative Efficacy (2009-2010) and Sterility Testing (2010-2012) groups. Also served as Microbiology representative on several new product development teams.

• Provided technical insight and leadership in the development of sterility test methods for new products in challenging formulations such as gels and other viscous materials containing potent antimicrobial agents.

• Analyzed sterility testing isolator practices and made significant changes to improve the asepsis of testing.

Microbial Contamination Solutions, LLC 2008-2009 Wernersville, Pa Founder/Senior Consultant

Established an independent consulting business to provide microbial contamination control expertise to pharmaceutical, medical device, and other industries.

• Provided web based accredited trainings through the Center for Professional Advancement, New Brunswick, NJ on control of microbial contamination in sterile and non-sterile products, and on conducting investigations of microbial contamination.

Arrow International/Teleflex Medical 2006-2007 Reading, Pa Principal Scientist

Led concept research efforts relative to the development of next generation antimicrobial central venous catheters. Designed studies and performed testing comparing company's antimicrobial products with competitor's products. Utilized CLSI procedures to determine potency (minimum inhibitory and cidal concentrations) of various antimicrobial agents against catheter related pathogens, and supervised the work of technicians performing such testing.

• Provided innovative ideas and reduced concepts to practice resulting in the filing as co-inventor of 5 US patent applications.

• Prepared and presented two posters at two major medical conferences (SCCM and AVA) demonstrating superior antimicrobial properties of company's products versus those of competitors.

• Trained sales force and new employees on the pathogenesis of central venous catheter related infection. Certified by company training department as company expert on this topic.

Bristol Myers Squibb, New Brunswick, New Jersey 2005-2006 Senior Research Scientist

Microbiology lab management position, responsible for all microbiological testing relative to validation and start up of a new clinical small volume parenteral manufacturing site.

• Prepared a proposal for replacement of sterility testing clean rooms with isolation technology.

• Prepared a validation master plan for critical equipment and processes in manufacturing and microbiology laboratory areas.

Enzon Pharmaceuticals, South Plainfield, NJ 2004-2005 Microbiology Manager

Responsible for all microbiological monitoring and product testing relative to biopharmaceutical product sterility assurance, including sterility, bioburden, microbial limits, pyrogens (LAL methods), and viable and nonviable particulate monitoring.

• Prepared annual trend analysis report for aseptic areas and recommended significant reductions in alert and action levels based on statistical data analysis.

• Recommended improvements to aseptic manufacturing process and purified water system to reduce microbial contamination risk.

ETHICON, INC., Somerville NJ 1998 –2004 Principal Scientist (2003 - 2004)

Responsible for support to R&D Team and Marketing groups relative to concept/developmental antimicrobial device work, and support to existing antimicrobial products. Key Achievements:

• Trained J&J Surgical Wound Care sales and marketing staff relative to the antimicrobial properties of SurgicelTM and BiopatchTM products. Efforts helped significantly increase product sales.

• Participated in the development of VICRYL Plus Antimicrobial Suture (Coated Polyglactin 910 With Triclosan).

• Chaired a Microbial Biofilm Symposium sponsored by J&J Corporate Office of Science and Technology. In collaboration with Infectious Disease experts from J&J affiliates, pulled together recognized leading authorities on this topic to educate key scientists from across the Corporation.

Manager, Microbiological Services (1998 - 2003)

Responsible for R&D Microbiology team leadership. Managed team activities relative to bioburden and dose audit testing of products to assure sterility, led investigations into product sterility issues, and supported R&D new product development activities. Also audited contract aseptic processing operations. Key Achievements:

• Led team effort to establish microbial barrier claim for DERMABOND Topical Skin Adhesive. FDA approval of this claim led to a 30% increase ($9MM) in sales for 2002.

• Participated in the preparation of Corporate J&J Water Policy and wrote section on failure analysis.

• Led team effort to validate reduced incubation time for biological indicators from 7 days to 3 days, resulting in a 4 day reduction in product release cycle time.

SOLOPAK PHARMACEUTICALS, Elk Grove Village, IL 1996 – 1997 Associate Director of Microbiology

Responsible for Microbiology groups at three small volume parenteral manufacturing plant sites in Chicago area. Key Achievements:

• Recommended specific improvements in water pretreatment systems at three plant sites, which resulted in significant improvement in microbial contamination control relative to aseptic processing.

OMJ Pharmaceuticals (A Johnson &Johnson Company), San German, PuertoRico 1994 - 1996

Quality Control Manager (1996)

Responsible for Management of Chemistry, Microbiology, Product Release, and Stability groups. Key achievements:

• Identified and resolved key scheduling problems in Chemistry area.

• Presented trainings to supervisors and lab associates regarding customer focus/World Class Concepts, and established key measurements to monitor performance. .

Microbiology Manager (1994 - 1995)

Responsible for product testing (sterility, bioburden, preservative efficacy, pyrogens), environmental monitoring (air, water, steam, etc.) and all other testing related to assuring that Company's products were sterile. Key achievements:

• Led investigation efforts related to environmental microbial contamination issues in aseptic and adjacent areas. Team oriented approach resulted in elimination of many root causes of contamination.

• Participated in FDA, DHSS (United Kingdom), and Corporate QA audits, which resulted in no major observations relative to the Microbiology area.

• Represented Company on Corporate Johnson & Johnson Sterilization Council. Actively participated in preparation of Corporate policies relative to aseptic processing.

IOLAB Pharmaceuticals (A Johnson &Johnson Company), San German, Puerto Rico 1989 - 1993

Regulatory Specialist (1992 - 1993)

Management level special assignment to prepare narratives relative to a new parenteral manufacturing facility as it related to the manufacture of a CBER regulated product. Key achievements:

• Gained hands on experience in preparation of Establishment License Application for biologic products. Provided narratives of all operations relative to manufacture of a sterile, lyophilized, diagnostic parenteral product. Also participated in preparation of Drug Master File and several NDAs.

Quality Control Manager (1989 - 1992)

Responsible for Management of Chemistry, Microbiology, Stability, and Product Release groups.

• Through implementation of measurement systems and focused corrective action, reduced average customer complaint throughput time from 30 days to 10 days, and average throughput time for chemical raw materials from 30 days to 8 days.

• Led project for CFC elimination in EO sterilization. Recommended elimination of in house sterilization of components with Ethylene Oxide-Freon. Qualification of contract sterilization facility resulted in an annual $100,000 savings.

COOPERVISION PHARMACEUTICALS/IOLAB Pharmaceuticals, San German, Puerto Rico 1985 - 1989

Technical Support Manager (1986-1989)

Responsible for supervising/coordinating the qualification and validation of all critical processes (sterilization, cleaning, depyrogenation, filtration, aseptic fill) and equipment related to the manufacture of sterile ophthalmic products. Primary Achievements:

• Led investigations into various product microbiological and particulate contamination issues, which led to corrective action and permanent resolutions.

EDUCATION

MS Microbiology, University of Arkansas, Fayetteville AR; BS Biology, Pittsburg State University, Pittsburg, KS

ORGANIZATIONS: Member PDA, ACS

PRESENTATIONS

• Spangler, D, Moss, S, Steinke, E, Rosenblatt, J. Extension Lines of Antimicrobial Central Venous Catheters: An In-Vitro Assessment of Antimicrobial Activity. Association for Vascular Access Annual Conference, Phoenix Arizona, Poster Presentation. September 2007.

• Spangler, D, Moss, S. In-Vitro Assessment of Antimicrobial Activity of Three Commercially Available Central Venous Catheters. Society for Critical Care Medicine Annual Conference, Orlando Florida, Poster Presentation Feb. 2007.

• Spangler, D. In-vivo energy applications for the prevention and treatment of microbial infections. Presented at Johnson & Johnson COSAT sponsored Energy Based Therapy Conference, Hyatt Regency Hotel, Princeton, NJ. Jan 14, 2004.

• Spangler, D. In-vitro assessment of antimicrobial effect of low-level direct current and silver on Staphylococcus aureus utilizing a membrane filtration test model. Poster presented at Johnson & Johnson COSATsponsored Energy Based Therapy Conference, Hyatt Regency Hotel, Princeton, NJ. Jan 14, 2004.

• Spangler, D. Oxidized Regenerated Cellulose & Acidic pH Applications for Infection Prevention. Presented at Johnson & Johnson COSAT sponsored Anti-Infective Inventory Meeting, Hyatt Regency Hotel, New Brunswick, NJ. March 26, 2002.

• Spangler, D. In-vitro Assessment of Microbial Barrier Properties of DERMABOND Topical Skin Adhesive. Presented to group of Surgeons at Emerging Trends in Wound and Surgical Incision Closure: A Focus on Topical Skin Adhesives, Park Hyatt Hotel, Chicago Illinois, Oct. 20, 2001.

• Spangler, D. Water System Failure Analysis. Presented at Johnson &Johnson Sterilization Sciences and Technology (SST) Technical Meeting on Water system Design & Testing. East Brunswick, NJ. Oct. 24-25, 2001.

• Spangler, D. Positive Sterility Test Investigations. Presented at CORD Microbiology subcommittee seminar on Microbial Control & Compliance, Ponce, Puerto Rico, Feb 8-9, 2000. Also presented at a Microbial Control & Compliance conference at Ortho McNeil Pharmaceuticals in Raritan, NJ in 1st Quarter, 1999.

• Spangler, D. Positive Sterility Test Investigations. Presented at Puerto Rico Society for Microbiology (Puerto Rico Chapter of American Society for Microbiology) 39th Annual meeting in San Juan, PR. June, '96, (In Spanish).

• Spangler, D. Control of Microcontamination in Purified Water Systems. Presented at USP Water Symposium, Sponsored by Johnson & Johnson, Mayaguez, Puerto Rico, Aug. 18, 1995.

• Spangler, D. Sanitization and Control of Microcontamination in Pharmaceutical Water Systems. Presented at Puerto Rico Society for Microbiology (Puerto Rico Chapter of American Society for Microbiology) 37th Annual meeting in San Juan, PR. June 10-11, 1994.

• Spangler, D et al (Puerto Rico Quality Assurance Regional Committee). Total Worker Involvement: Defining a process for the continuous improvement of quality, productivity, and efficiency of manufacturing operations, through total worker involvement. Presented at Johnson & Johnson Annual Quality Conference in Bushkill, Pa. 1990.

• Spangler, D. Automated Microbiology Analysis: Utilization of gas chromatography and fatty acid analysis in the identification of microorganisms. Johnson & Johnson 7th Quality Systems Conference, San Juan, Puerto Rico. 1989.

• Spangler, D. Sanitization and Control of Water Systems. Johnson & Johnson Sterilization Sciences Seminar: An Education Program on Water Quality Systems and Design. Pp. 145-154. 1989.

PEER REVIEWED PUBLICATIONS

• Bhende, S., Spangler, D. In vitro assessment of BIOPATCH* Antimicrobial Dressing using zone of inhibition assay. Journal of Infection Control and Hospital Epidemiology. Vol. 25, No. 8, August 2004.

• Spangler, D, Rothenburger, S, Nguyen, K., Jampani, H., Weiss, S., Bhende, S. In vitro Antimicrobial Activity of Oxidized Regenerated Cellulose against Antibiotic Resistant Microorganisms. Surgical Infections, Vol 4, No. 3, Oct. 2003.

• Rothenburger, S., Spangler, D., Bhende,. S., Burkley, D. In vitro Antimicrobial Evaluation of Coated VICRYLR Plus Antimicrobial Suture (Coated Polyglactin 910 With Triclosan) Using Zone of Inhibition Assays, Surgical Infections, Vol. 3, Supplement, Dec. 2002.

• Bhende, S., Rothenburger, S, Spangler, D., Dito, M. In Vitro Assessment of Microbial Barrier Properties of Dermabond Topical Skin Adhesive, Surgical Infections, Vol.3, Number 3, Oct.2002.

• Spangler, D., Emert, G. Simultaneous Saccharification/Fermentation with Zymomonas mobilis. Biotechnology and Bioengineering, Vol. XXVIII, Pp.115-118. 1986.

PATENTS

US 6514517 "Antimicrobial Coatings for Medical Devices" Spangler, D, Jamiolkowski, D, Rothenburger, S. 2/4/03.

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