Daniel Nicolas

Thousand Oaks, CA *****

ac6e43@r.postjobfree.com 805-***-**** www.linkedin.com/in/Daniel-Nicolas/

Professional Summary

Innovative and pragmatic business professional with expertise in project management, QA, and R&D. Extensive background in Operations Process Development with proven track record in strategic planning & execution, data & risk analysis, and Lean/Six Sigma methodologies. Comprehend complex concepts; analyze and interpret ideas quickly into cost-effective global strategy. Commercialize R&D pipeline, improving product & process quality, reducing variable cost of production, and developing competitive advantage.

Project Management Quality Assurance Chemistry Microbiology

Molecular Biology Bio-Chemistry Engineering FDA & USDA Standards

Professional experience

MONSANTO, GLOBAL PRODUCTION TECHNOLOGY, Oxnard, CA 2010 – 2016

Research Associate II – Project Lead, Innovation and Engineering

Managed and supported research projects across the Global Supply Chain addressing quality issues, improving processes, and commercializing the R&D pipeline. Project Manager and researcher for Innovation and Engineering team cross-functional research projects, focused on improving SOP’s, GMP’s, and CAPA for operations processes; complex data analysis. Quality oversight and review, SME on microbiological contamination, disinfectant efficacy studies, and chemical effects to developmental biology.

Leader within the Quality Assurance organization driving harmonization, standardization, and improvement in the areas of quality, risk and cost management, safety, and sustainability.

Developer and owner of strategy, policy, technology, and protocols for platforms across the global supply chain addressing microbiological contamination, chemical efficacy studies, and physical/chemical effects to developmental biology.

Collaborated with production, operational teams, and customers; addressing process issues and providing support and assistance via technical services to address customer complaints.

Materials allocation and analysis, vendor review; working closely with QA/QC testing in developing opportunities for process improvement and assay development.

Achieved business goals through continuous improvement projects managing teams cross-functionally between Operations, Production, QA, Engineering & Technology, Research and Development, and Finance; established and lead joint research efforts with third-party companies.

Attributed cost avoidance, cost savings, opportunity cost, and potential revenue to business critical processes or products, creating and assessing cost effective / innovative solutions, constructing cost benefit analyses, using statistical analysis to definitively assess beneficial effects, and strategically overseeing development and commercialization while troubleshooting sources of variation.

Primary developer of numerous confidential processes, internally published; 4 invention disclosures filed between 2012–2016. Presenter and annual Contributor (Award Winner) to Technical Committee of Monsanto (TCM).

QA auditing, document development and review to ensure compliance; process development and validation; batch review and corrective and preventive actions.

Project Management through all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design, testing, and implementation planning); average project ROI over 85% with a cumulative cost savings of over $5M per annum.

Laboratory manager (USDA-certified); microbiology, experimental design, complex data analysis, chemical testing, developmental biology, and chemical genetics.

Daniel Nicolas ac6e43@r.postjobfree.com Page Two

THE CHEESECAKE FACTORY, Calabasas, CA 2009 – 2010

Quality Assurance, QA / QC Technician, Corporate Bakery Division

Conducted microbiological testing and analysis for all incoming ingredients, intermediate ingredients, finished products, and environmental contact services. Maintained and applied GMP, GLP, and HACCP standards. Directed laboratory management, instrument calibration, and preventive maintenance. Handled data management and system validation. Assisted in development and improvement of sanitation protocols.

Directed quality inspections related to validation of sanitation practices in production and manufacturing, determining and implementing corrective actions.

Exercised discretionary stop / hold on operations, ensuring quality requirements were met.

Conducted allergen specific protein testing and chemical titration, meeting all FDA guidelines.

QUEST DIAGNOSTICS, Canoga Park, CA 2009

Laboratory Technician III, Mycology / AFB

Organized and prepared clinical samples, reagents, and controls. Performed complex assays, troubleshooting, and test validation. Tracked and maintained inventory of consumable / perishable items. Conducted preventive maintenance, calibration, and sample verification. Tracked logs, posed data, managed multivariate testing, and coordinated with physicians.

Improved clinical sample assay process efficiency ~20% by prioritizing sample allocation relative to compound testing constraints.

Worked with Bio-Hazard Level 3 material, ensuring safe handling of pathogenic / hazardous materials.

Supported Clinical laboratory scientists in pathogen identification, establishing context of readability and sample viability, and communicating directly with attending physicians to allocate additional samples and relay life-threatening results.

Education

Master of Business Administration (MBA), Sustainable Operations,

California Lutheran University, Thousand Oaks, CA

Bachelor of Science (BS), Bio-Chemistry and Molecular Biology,

California Lutheran University, Thousand Oaks, CA

Certifications and Professional Development

Six Sigma Certified: Green Belt – Monsanto

Lean Certified Practitioner – Monsanto

ISO 9001:2008 Certified: Internal Auditor – Monsanto

Advanced Ergonomics Certified: US Ergo

Coaching Conversations: Lee Hecht Harrison

Situational Leadership: Ken Blanchard

(Management Training) People Leadership Learning Series (PLLS): Monsanto

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