PROFILE

Seasoned and autonomous background as a Change Agent, Management Innovator and Process Development Specialist in plant operations, quality compliance, manufacturing processes and program implementation in today’s deadline-driven industry. Excellent technical writer and preparer of process documentation and metrics with exceptional clarity. Very successful problem solver and leader of cross functional teams charged with providing process solutions and driving quality initiatives.

• Recognized for excellent performance of auditing, tracking, waste management, plant operations, logistics, internal auditing, and regulatory compliance in commercial and industrial plant situations.
• High-caliber leadership experience in multi-project management, strategic planning and stakeholder relations.
• Proficient as a self-starting manager in all aspects of the project process, including requirements identification, resource allocation, workflow planning, and relationship building.
• Expertise in the administration of complex projects and process improvements in connection with top management, key decision-makers, union representatives and professional field staff.
• Self-motivated to achieve peak performance, surpass quality standards, streamline daily operations, and meet performance metrics in a timely fashion.
• Familiar with cGMP, FDA, EMEA, ISO 9001, LEED, GXP and associated state and federal regulations and guidelines; experienced researcher acquiring of US patents; Six Sigma Belts, DMAIC and Lean Manufacturing.
• Solid background in failure modes & effects analysis (FMEA), DATA analysis, statistical analysis, graphical analysis, work flow diagrams and relational databases.
• Facilitation of annual facility shutdowns for calibration, validation, maintenance and upgrades; performance of preventative and predictive maintenance of key systems and process equipment.
• Multi-tasking talents and attention to detail in time-sensitive and potentially critical situations.

AREAS OF EXPERTISE

• Alignment of policy with strategic plans
• Cost/Benefit Analysis
• Six Sigma Lean Manufacturing
• Process Validation/Cleaning Validation
• GAP Analysis
• CAPA Quality Systems Mgmt
• Cost-of-Quality Analysis
• Financial Acumen
• Process Improvements
• Life-Cycle Mgmt
• Work Flow Definition

EMPLOYMENT ACCOMPLISHMENTS

Senior Manager - Quality Assurance/Quality Control
Confidential, Sacramento, CA July 2008 to Apr 2009

• Utilized engineering change control process to analyze and obtain necessary approvals for changes and prevent extremely costly alterations from design specification with negative impact on project schedule, costs and permitting.
• Strict design and code enforcement and assurance that permit conditions were correctly implemented as required.
• Applied corrective action-preventative action procedure based on root cause analysis for all non-conformances.
• LEED commissioning implementation. Assisted with document control process.

Manager - Quality Technical Services
Confidential, Rancho Cordova, CA April 2006 to July 2008

• Successfully reduced cost of Validation by 48% by implementing ICH Q9 risk assessment and impact analysis to determine qualification and validation requirements without compliance compromise.
• Leveraged commissioning performed in capital projects to further reduce qualification of equipment costs.
• Re-defined clean room classification based on the current manufacturing activities, which reduced costly PMs and air balance requirements for areas using closed systems and no product exposure risk (following ISPE Baseline guides)
• Initiated Six Sigma Lean Manufacturing methodology making improvements to cleaning & cleaning validation program reducing turn around cycle-time.

Principal Engineer/Quality Engineer
Confidential, Hayward, CA 2005 to 2006

• Eliminated costly process delays due to facilities engineering issues with QA compliance by simplifying implementation requirements and creating periodic cross functional compliance meetings to process documents, changes, non-conformances.
• Managed change control process for all facilities and capital projects teams. Managed Validation projects.
• Rewarded by Quality Director for performance at FDA inspection.

Principal Staff Engineer/Supervisor - Validation Department
Confidential, Hayward, CA 2003 to 2005

• Dramatically improved compliance in 21 CFR Part 11 issues, process validation and qualification by re-developing and re-staffing a validation department (inherited from previous manager).
• Utilized contractors to reduce validation backlog by 85% and eliminated Part 11 risks, while re-staffing the department. Awarded for Operational Excellence.

Senior Manufacturing Engineering & Facilities Manager
Confidential, Campbell, CA 1995 to 2003

• Maintained Critical Path during manufacturing process validation by (1) training process team regarding all process equipment treatment and service (2) retrofitting fermenter skid as needed to correct errors causing contamination problems (3) Improvements to autoclaves, bio-waste systems, VHPs and Isolators, (4) solved problems with utility systems, ensuring product launch schedule.
• Responsible for EH&S, Validation, Process Engineering, Facilities Maintenance and Capital Projects.
• Re-engineered high pressure cylinder process gas system to a fully monitored-alarming autodialer, multi-dewar/Six Pak auto-switch system reducing accident potential and risk of losing gas during processing (extremely high value product).
• Reduced risk of product loss by developing an integrity test process for the tangential filtration apparatus and training process group on new SOP for assemble.
• Improved sterilization technology on VHP and Alpha-Beta flange system on Isolators.
• Improved temperature control for all incubators, refrigerators and freezers by installing highly visible, multi-channel, color pen chart recorders in high traffic zone in hallway where it can easily be monitored.
• Improved sub-zero performance of chillers by developing an azeotropic mixture of Dowtherm and ethanol.
• Permitted Improved and upgraded emergency switch gear and fuel storage system for long term storage.
• Worked with contractors on installation of a new 6-7000 sq. ft .QC Laboratory building and systems,
• Managed annual shutdowns for the facility reducing cost (15%) by managing contractor from a Master Plan for calibration, validation, Annual PMs, and capital projects. Use of compliance matrix to ensure all records were delivered.
• Registered as Designated Responsible Manager by CDC, to be responsible for Neurotoxin and shipments to Ireland. Also managed the employee inoculation program with Dr. Peter Greany.

QA/QC & Process Laboratory Manager
Confidential, Newark, CA 1988 to 1995

• Obtained support from upper management to redesign and expand the QC and Process Laboratory to accommodate business needs. Staffed with qualified chemists and engineers (10 to 12).
• Used Lab to develop an aggressive raw materials quality operation which having major impact on the operations and the business by:
• Improving plant’s front end performance and reduced fouling by 35% which reduced Heat Exchanger and thin film evaporator unexpected shutdowns and required maintenance.
• Improving hydro-treating section by removing Ni-Mo catalyst poisons (Silicon, Phosphorus, Chlorine, Sulfur, Nitrogen) reducing pore plugging and extending the catalyst life cycle for longer (40%) run times and reduced maintenance costs
• Improved product content and stability as follows: hydro-treater process reduced PNAs, Nitrogen, Sulfur and Dioxin. The fractionators process improved giving a tighter boiling range.
• Reduced waste water treatment cost by $250,000 per quarter by pilot plant experimentation and selection of best technology for oxidative chemistry (CLO2). Improved compliance with sanitary district preserving the permit.
• Assisted with developing waste water treatment business (Vacuum truck service) by making separations using coagulants, surfactants, polymers, etc. and splitting phases-solids to disposal, water tested and discharged to sanitary sewer.

• .Expanded business in Northern California by opening a specialty gas plant inside an industrial gas repackaging facility to market pure gases, mixtures, chemical gases, cryogenics, liquid helium and gas equipment.
• Third plant in sales of the 12 US plants.
• Western US Regional Emergency Responder for toxic gases responded to 5 emergencies (HF, HLC, Arsine, BCL3).

Clinical Manufacturing Research Organic Chemist
Confidential, Palo Alto, CA 1981 to 1984

• Researched peptide purification process, fractional chromatographic separation, Preparative HPLC, desalting and re-crystallization followed by successful scale up to multi-gram quantities.
• Clinical manufacture of capsules, tablets, solutions, semi solids and parenterals and radio-labeled products for clinical studies

EDUCATION

B.S. Degree in Chemistry and Biological Science.
Master Thesis Board in Chemical Engineering.
Master of Business Administration.

PROFESSIONAL ACTIVITIES

• Lean Manufacturing and Six Sigma Black Belt in training; Six Sigma Green Belt certified.PMP Certification in-training.
• Member of the Project Management Institute, International Society of Pharmaceutical Engineers, ASTM, American Society for Quality and International Society for Automation.
• Researched and authored industry articles including chemical processes and waste water treatment technology.