Senior Information Technology Manager

Biotechnology, Pharmaceutical, & Chemical Environments

Client-focused and people-oriented with extensive experience in information technology management within engineering and other high-technology environments. Facilitate corporate mission through strategic thinking and transforming technological information into workable formats. Successful in identifying, prioritizing, and optimizing workflow processes and procedures through intricate business planning and executing complex engineering strategies. Core competencies include:

Applications and Project Development
Business Process Re-engineering
Information Systems Design
Continuous Quality Improvement
User Training and Support

Facilitating Change Management
Data Modeling & Database Design
Financial & Statistical Analysis
Engineering Applications & Modifications
Cross-Functional Team Leadership

Numerous achievements in managing projects, performing systems analyses, and providing information resources for various business functions, including manufacturing and R&D. Work closely and effectively with multi-level staff in both domestic and global organizations. Consensus builder with strong leadership, technical, interpersonal, and crisis management skills.

Key Accomplishments

Shortened approval time for Capital Expenditure Proposals (CEPs) by as much as 75% and ensured compliance with company’s business policies through creation and implementation of electronic system for managing CEPs and collecting electronic signatures.
Prevented $5 million problematic and premature rollout of data visualization and integration software by identifying data infrastructure weaknesses that could not support software and user requirements..
Played pivotal role in optimizing plant procedures and eliminating risk to approximately $100 million of annual company business. Instrumental in providing configurable document management system for plant SOPs and facilitated compliance with ISO 9000 documentation requirements within several production plants.

Generated and delivered critical economic data to senior management for 12 alternative manufacturing processes and scenarios within “product Alpha” specifications. Led urgent evaluation efforts without any lead time to evaluate critical part of company’s potential business acquisition.

Professional Experience

Genencor International, a Danisco Company (formerly Eastman Kodak), Rochester, NY 1976–2004

Diversified biotechnology firm with $410 million in annual revenues. International manufacturer of industrial enzymes and other bio-chemicals. Discover, develop, and sell biocatalysts within industrial, consumer, and agri-processing markets. Additionally, serve healthcare market in creating drug development platforms in targeted bio-therapeutics for cancer.

Senior Applications Analyst (1998–2004)

Directed and performed corporate-level application development, support, and maintenance for supply chain, manufacturing, quality assurance, and finance organizations. Managed and optimized effectiveness of and provided user support for Lotus Notes and Domino, Oracle Database, MAXIMO Computerized Maintenance Management System (CMMS), and Siemens Unilab Laboratory Information Management System (LIMS). Ensured compliance with 21 CRF Part 11 and Sarbanes-Oxley (SOX). Point of contact for GAMP4, cGMP, and system validation.

Elmer P. Smith, PE

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Professional Experience (continued)

Led development efforts in designing Lotus Notes application and document change management process for IT systems. Implementation resulted in compliance with Sarbanes-Oxley Act. Rated as “best auditing system” by Price Waterhouse Coopers.

Conceived, developed, and implemented Corporate QA and Regulatory Processes designed to provide means for effectively storing and retrieving product formations within LIMS system. Achieved improved workflow optimization through eliminating manual recordkeeping and previous frequent short notice.

Directed Y2K compliance project for all embedded systems in company’s process equipment in preventing potential disruptions to manufacturing operations of $200–$300 million company.

Designed and built application to manage and collect electronic approval signatures and reduced approval and follow-up time for process manufacturing events by 50%. Implementation of initiative also eliminated one-week turnaround time for obtaining copies of prior product events, now available in electronic form 24-7, and enabled product analyses never previously attempted.

Remedied problematic event logging and corrective action reporting by overseeing maintenance and development of computerized event logging system started by external contractor. Additionally worked with plant ISO 9000 teams to further optimize processes and address concerns submitted by external auditors.

Increased effectiveness and efficiency of corporate operations by architecting and building over 40 custom Lotus Notes applications initiated in response to my proactive proposals and requests from business areas.

Senior Engineer (1986–1997)

Oversaw and performed process engineering studies for site and company management. Served as process control engineer for distributed control system (DCS) at Lexington Avenue plant. Worked closely and effectively with operations and maintenance in troubleshooting processes and equipment. Provided on-site computer support for operations, engineering, and site management. Managed and supported statistical analysis tools, including modeling, statistics, ANOVA, statistical process control, design of experiments (DOE), and graphics.

Ensured successful ramp up of $15 million plus facility during commissioning of distributed control system. Worked closely with vendor to correct system bugs in beta test software and with operations personnel to correct programming errors.

Saved up to 100 man hours per project and promoted process standardization throughout company. Instrumental in producing “agitation scale-up and analysis kit” used by fermentation engineer as standardized starting point for analyzing processes.

Designed and implemented unique control algorithm to provide mission critical capability for feeding sugar solutions at very low flow rates to small scale fermentations. Implementation of initiative saved company

$1 to $4 million, including depreciation effects from requiring additional equipment.

Key player in preventing operational disruptions when facility was required to vacate former parent company’s computer systems under very aggressive timeframe. Managed project initiatives and implemented necessary systems to migrate applications and process data. Recognized for performance in meeting tight deadlines and producing improved replacement system.

Elmer P. Smith, PE

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Professional Experience (continued)

Successful in building and introducing benefits of process modeling for manufacturing plant in Finland using process modeling software (Gensym G2 with BDS). Information gained and subsequent modeling with BioPro Designer resulted in 50% increase in plant capacity.

Saved process engineering several hours per week and provided numerous benefits of having standard method of analysis. Architected and deployed sets of standardized process data visualization graphs for SAS/Graph, which ultimately helped engineers and scientists improve technical performance of processes.

Previous Engineering Experience:

Research Engineer (1983–1985)

Investigated parameters affecting production of amino acids via aerobic fermentation utilizing chemical engineering principles and practices. Served on design team of Lexington Avenue green field development facility to ensure suitability of facility to goals and tasks. Designed and executed experiments to establish quantitative impact of off-gas composition on rate of production for particular amino acid.

Education and Licenses

B.S.—Chemical Engineering, Case Western Reserve University, Cleveland, Ohio

Professional Engineering License—State of New York

FCC Extra Class Amateur Radio License