Fernando Garcia has over 15 years of experience in the regulatory and product stewardship field, specializing in fast-tracking new product approvals. He has worked at Amyris as their Senior Director of Regulatory Affairs, leading a team that obtained global regulatory registrations and approvals for renewable fuels, chemicals, and other products. Prior to that, he spent 13 years at Bombardier managing their regulatory compliance programs across North America, Latin America, Europe, and Asia. He has extensive experience interfacing with regulatory agencies around the world including EPA, FDA, and others.
2015 TFA Green Chemistry Barriers & AcceleratorsTess Fennelly
This document summarizes a report on barriers to adoption of green chemistry and ways to accelerate its use in supply chains. It identifies nine key deterrents slowing green chemistry's growth, including lack of agreed definitions, supply chain complexity, incumbent advantages, confusion, and more. It also describes current drivers like regulations and consumer awareness. Four accelerators are proposed to change paradigms: collaboration across stakeholders, technology forcing by large companies, compromise, and education. Applying these accelerators in a cooperative model of supply chain interactions could help diffuse inhibitors and fuel availability and adoption of greener chemicals.
The document provides an update on the implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) at the Hanford Site. It outlines the key requirements and deadlines established by OSHA for GHS implementation, and describes the process undertaken at Hanford to meet these requirements through training, hazard labeling, database updates, and revised procedures. An inter-contractor working group was established to coordinate the implementation efforts across Hanford contractors.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
Antone Mello has over 25 years of experience in polymer chemistry, manufacturing, and environmental health and safety. He has expertise in product development, regulatory compliance, manufacturing, and troubleshooting. As a sole proprietor, he has performed safety training and procedures to help companies obtain ISO9001 certification. He has also developed novel coatings, chemicals, and additives. Previously, he worked as a chemist and helped develop new products, scale up manufacturing, and ensure quality and regulatory compliance for a chemical company. He has a background in analytical chemistry and helped with environmental testing and regulatory projects.
The document provides an overview of product stewardship and global product regulatory compliance challenges. It discusses how the number of environmental regulations has increased globally in recent years. Product stewardship and compliance is a strategic issue for multinational corporations due to risks like supply chain disruptions and barriers to innovation from the proliferation of non-harmonized regulations across jurisdictions.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
The document provides details about an expert in managing factory operations and ensuring quality compliance. Some key experiences include overseeing production processes, quality management systems, statutory compliance, and international product registrations. The professional has over 30 years of experience in research and development, quality assurance, and environmental assessments across various roles within the agrochemical industry.
2015 TFA Green Chemistry Barriers & AcceleratorsTess Fennelly
This document summarizes a report on barriers to adoption of green chemistry and ways to accelerate its use in supply chains. It identifies nine key deterrents slowing green chemistry's growth, including lack of agreed definitions, supply chain complexity, incumbent advantages, confusion, and more. It also describes current drivers like regulations and consumer awareness. Four accelerators are proposed to change paradigms: collaboration across stakeholders, technology forcing by large companies, compromise, and education. Applying these accelerators in a cooperative model of supply chain interactions could help diffuse inhibitors and fuel availability and adoption of greener chemicals.
The document provides an update on the implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) at the Hanford Site. It outlines the key requirements and deadlines established by OSHA for GHS implementation, and describes the process undertaken at Hanford to meet these requirements through training, hazard labeling, database updates, and revised procedures. An inter-contractor working group was established to coordinate the implementation efforts across Hanford contractors.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
Antone Mello has over 25 years of experience in polymer chemistry, manufacturing, and environmental health and safety. He has expertise in product development, regulatory compliance, manufacturing, and troubleshooting. As a sole proprietor, he has performed safety training and procedures to help companies obtain ISO9001 certification. He has also developed novel coatings, chemicals, and additives. Previously, he worked as a chemist and helped develop new products, scale up manufacturing, and ensure quality and regulatory compliance for a chemical company. He has a background in analytical chemistry and helped with environmental testing and regulatory projects.
The document provides an overview of product stewardship and global product regulatory compliance challenges. It discusses how the number of environmental regulations has increased globally in recent years. Product stewardship and compliance is a strategic issue for multinational corporations due to risks like supply chain disruptions and barriers to innovation from the proliferation of non-harmonized regulations across jurisdictions.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
The document provides details about an expert in managing factory operations and ensuring quality compliance. Some key experiences include overseeing production processes, quality management systems, statutory compliance, and international product registrations. The professional has over 30 years of experience in research and development, quality assurance, and environmental assessments across various roles within the agrochemical industry.
This document is a resume for Terry Chan summarizing their 26 years of experience in the pharmaceutical industry working in regulatory affairs, regulatory compliance, and analytical chemistry. They are currently seeking a new challenging opportunity to utilize their skills and contribute to a successful team. Their resume provides details on their employment history including roles at McNeil Consumer Healthcare, Pfizer Inc., and Warner Wellcome Consumer Healthcare. It also lists their computer skills and education with a BSc in Chemistry from the University of Glamorgan in the UK.
Mark Cheesman has over 15 years of experience in environmental, health, and safety compliance in the oil and gas industry. He has expertise in developing and implementing compliance programs, permitting, reporting, and agency interactions. As Manager of Environmental Affairs for CITGO Petroleum Corporation, he managed a staff and oversaw all environmental compliance and reporting. He has also worked as a consultant providing regulatory compliance assessments and programs.
David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.
This resume summarizes Jason Gillette's experience in regulatory compliance and quality systems for life science companies over 17+ years. He currently serves as Vice President of Regulatory Compliance at Westminster Pharmaceuticals, where he helped the startup secure contracts with major wholesalers and distributors. Prior to this role, Gillette held regulatory and quality roles at several pharmaceutical and medical device companies, helping to ensure compliance with FDA regulations. He has extensive experience implementing quality management systems, conducting audits, and managing regulatory projects.
Gregory Martin Davis is seeking a position as Quality Manager for Plastics, Packaging Manufacturing, Food & Beverage Operations. He has over 35 years of experience in quality management roles, developing quality systems for companies ranging from startups to Fortune 100 enterprises. His experience spans industries including plastics molding, food/beverage packaging, medical devices, aerospace, and more. He has a proven track record of eliminating defects, improving yields and processes, achieving regulatory compliance, and driving overall business growth through quality leadership.
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
Parveen Bhatarah has over 15 years of experience in pharmaceutical management, API development, drug substance manufacturing, technology transfer, and formulation development. They have successfully developed, scaled up, and manufactured a wide range of drug substances and formulations, and have transferred technologies for commercial manufacturing. Parveen also has experience evaluating and qualifying CMOs, building industry partnerships, and presenting scientific findings to regulatory agencies.
Stephen Colletta has over 20 years of experience leading complex projects in pharmaceuticals, medical devices, biotechnology, and validation. He has a proven track record of defining project requirements, gaining stakeholder support, and successfully launching new products. Some of his accomplishments include developing technical transfer specifications for a $300 million bird flu vaccine manufacturing plant, preventing a $20 million drug recall through root cause analysis, and launching 4 new cardiac drug lines that increased company revenue from $1.2 million to over $300 million.
BioLargo Deck for LD micro 2019 06042019Alex Evans
BioLargo is an innovative solutions provider with patented products and technologies. It has 20 patents and 5 pending patents across diverse markets including clean air solutions, wound care solutions, and engineering services. BioLargo's management team has extensive industry experience averaging over 35 years. Some of BioLargo's key products and technologies include CupriDyne Clean for odor control, the Advanced Oxidation System for clean water, and SkinDisc for advanced wound care. BioLargo is focused on commercializing these solutions and driving continued growth.
The document is a resume for Craig A. Dillworth, highlighting his 20+ years of experience in B2B sales management and operations leadership for a global Fortune 500 company. It summarizes his roles leading significant growth of a custom nitrogen gas generator business from $2 million to $15 million annually. It also outlines his areas of expertise, career highlights transforming sales teams and securing global accounts, and background in process engineering solutions.
The document is a curriculum vitae for Santanu Roy that outlines his career experience and qualifications. Some key points:
- Santanu has over 10 years of experience in regulatory affairs and quality assurance roles for pharmaceutical companies in India.
- His experience includes preparing regulatory submissions for markets like the US, Asia, Africa and preparing responses to deficiencies.
- Currently he works as manager of regulatory affairs at Glenmark Pharmaceuticals where he is responsible for CMC strategies and submissions.
R.D.PRABHAKARA REDDY is seeking assignments in pharmaceuticals with over 16 years of experience in quality assurance for APIs. He currently works as Assistant General Manager of Quality Assurance at Srikar Laboratories Pvt Ltd. He has strong understanding of GMP guidelines and experience handling inspections from regulatory bodies like US FDA, UK MHRA, and Australian TGA. He is experienced in supplier audits, compiling dossiers, and ensuring compliance with global regulatory requirements for markets like US, EU, Japan and Canada.
Mr. Jose D. Santiago is a senior consultant with over 30 years of experience in quality assurance and compliance for pharmaceutical, biotechnology, and medical device companies. He has expertise in quality systems, GMPs, validation, auditing, and remediation projects. Santiago has worked with multiple companies in regulatory compliance roles, including serving as the Consent Decree Champion Director at McNeil Healthcare during an FDA consent decree. He holds a Bachelor's degree in Chemistry/Biology and is certified in GMP training, CAPA/risk analysis, and complaint investigations.
Nathan Peters has over 15 years of experience in marketing and business management roles. He is currently the Marketing Director at ChemADVISOR, Inc., where he has led marketing efforts and increased sales volume. Prior to that, he held engineering and sales roles at various chemical companies, demonstrating expertise in areas like process engineering, technical service, and account management. He holds a BS in Chemical Engineering and an MBA.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
This document is a resume for Terry L. Sole, who has over 30 years of experience in business development, project management, and operations management in various industries including mining, engineering, construction, and government. Sole holds multiple technical degrees and professional registrations. Their experience includes developing over $1 billion in new opportunities, managing projects and business units, directing P&L operations, and holding senior management roles with major companies.
This document is a resume for Terry Chan summarizing their 26 years of experience in the pharmaceutical industry working in regulatory affairs, regulatory compliance, and analytical chemistry. They are currently seeking a new challenging opportunity to utilize their skills and contribute to a successful team. Their resume provides details on their employment history including roles at McNeil Consumer Healthcare, Pfizer Inc., and Warner Wellcome Consumer Healthcare. It also lists their computer skills and education with a BSc in Chemistry from the University of Glamorgan in the UK.
Mark Cheesman has over 15 years of experience in environmental, health, and safety compliance in the oil and gas industry. He has expertise in developing and implementing compliance programs, permitting, reporting, and agency interactions. As Manager of Environmental Affairs for CITGO Petroleum Corporation, he managed a staff and oversaw all environmental compliance and reporting. He has also worked as a consultant providing regulatory compliance assessments and programs.
David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.
This resume summarizes Jason Gillette's experience in regulatory compliance and quality systems for life science companies over 17+ years. He currently serves as Vice President of Regulatory Compliance at Westminster Pharmaceuticals, where he helped the startup secure contracts with major wholesalers and distributors. Prior to this role, Gillette held regulatory and quality roles at several pharmaceutical and medical device companies, helping to ensure compliance with FDA regulations. He has extensive experience implementing quality management systems, conducting audits, and managing regulatory projects.
Gregory Martin Davis is seeking a position as Quality Manager for Plastics, Packaging Manufacturing, Food & Beverage Operations. He has over 35 years of experience in quality management roles, developing quality systems for companies ranging from startups to Fortune 100 enterprises. His experience spans industries including plastics molding, food/beverage packaging, medical devices, aerospace, and more. He has a proven track record of eliminating defects, improving yields and processes, achieving regulatory compliance, and driving overall business growth through quality leadership.
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
Parveen Bhatarah has over 15 years of experience in pharmaceutical management, API development, drug substance manufacturing, technology transfer, and formulation development. They have successfully developed, scaled up, and manufactured a wide range of drug substances and formulations, and have transferred technologies for commercial manufacturing. Parveen also has experience evaluating and qualifying CMOs, building industry partnerships, and presenting scientific findings to regulatory agencies.
Stephen Colletta has over 20 years of experience leading complex projects in pharmaceuticals, medical devices, biotechnology, and validation. He has a proven track record of defining project requirements, gaining stakeholder support, and successfully launching new products. Some of his accomplishments include developing technical transfer specifications for a $300 million bird flu vaccine manufacturing plant, preventing a $20 million drug recall through root cause analysis, and launching 4 new cardiac drug lines that increased company revenue from $1.2 million to over $300 million.
BioLargo Deck for LD micro 2019 06042019Alex Evans
BioLargo is an innovative solutions provider with patented products and technologies. It has 20 patents and 5 pending patents across diverse markets including clean air solutions, wound care solutions, and engineering services. BioLargo's management team has extensive industry experience averaging over 35 years. Some of BioLargo's key products and technologies include CupriDyne Clean for odor control, the Advanced Oxidation System for clean water, and SkinDisc for advanced wound care. BioLargo is focused on commercializing these solutions and driving continued growth.
The document is a resume for Craig A. Dillworth, highlighting his 20+ years of experience in B2B sales management and operations leadership for a global Fortune 500 company. It summarizes his roles leading significant growth of a custom nitrogen gas generator business from $2 million to $15 million annually. It also outlines his areas of expertise, career highlights transforming sales teams and securing global accounts, and background in process engineering solutions.
The document is a curriculum vitae for Santanu Roy that outlines his career experience and qualifications. Some key points:
- Santanu has over 10 years of experience in regulatory affairs and quality assurance roles for pharmaceutical companies in India.
- His experience includes preparing regulatory submissions for markets like the US, Asia, Africa and preparing responses to deficiencies.
- Currently he works as manager of regulatory affairs at Glenmark Pharmaceuticals where he is responsible for CMC strategies and submissions.
R.D.PRABHAKARA REDDY is seeking assignments in pharmaceuticals with over 16 years of experience in quality assurance for APIs. He currently works as Assistant General Manager of Quality Assurance at Srikar Laboratories Pvt Ltd. He has strong understanding of GMP guidelines and experience handling inspections from regulatory bodies like US FDA, UK MHRA, and Australian TGA. He is experienced in supplier audits, compiling dossiers, and ensuring compliance with global regulatory requirements for markets like US, EU, Japan and Canada.
Mr. Jose D. Santiago is a senior consultant with over 30 years of experience in quality assurance and compliance for pharmaceutical, biotechnology, and medical device companies. He has expertise in quality systems, GMPs, validation, auditing, and remediation projects. Santiago has worked with multiple companies in regulatory compliance roles, including serving as the Consent Decree Champion Director at McNeil Healthcare during an FDA consent decree. He holds a Bachelor's degree in Chemistry/Biology and is certified in GMP training, CAPA/risk analysis, and complaint investigations.
Nathan Peters has over 15 years of experience in marketing and business management roles. He is currently the Marketing Director at ChemADVISOR, Inc., where he has led marketing efforts and increased sales volume. Prior to that, he held engineering and sales roles at various chemical companies, demonstrating expertise in areas like process engineering, technical service, and account management. He holds a BS in Chemical Engineering and an MBA.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
This document is a resume for Terry L. Sole, who has over 30 years of experience in business development, project management, and operations management in various industries including mining, engineering, construction, and government. Sole holds multiple technical degrees and professional registrations. Their experience includes developing over $1 billion in new opportunities, managing projects and business units, directing P&L operations, and holding senior management roles with major companies.
1. Fernando J. Garcia
128 Blackstone Drive Danville, CA 94506 510.387.2243 fernandogarcia128@comcast.net
REGULATORY & PRODUCT STEWARDSHIP DIRECTOR
Executive Engagement Regulatory Strategies & Execution Regional & Global Product Introductions
Regulatory Influence & Advocacy Policy,Process & System Development Rapid Product Commercialization
Product Vetting & Tracking Regulatory Team Leadership & Scientific Collaboration Subject Matter Expert (SME)
Innovative Regulatory Executive with years of experience commercializing biotechnology products in OEM and clean-tech/life
sciences industry sectors.Outstandingcommunicator known forgainingtrust of executives, government officials, and keypersonnel
to drive product introductionsthrough regulatory-centric strategies. MS,University of California at Irvine.
Background: Published former laboratory researcher known for developing strategies and introducing approaches to fast-track
new product validation and approvals; experience with new chemical registrations, fuel registration and validation, and cosmetic /
consumer product R&D and approvals; familiar with DEA List 1 Chemicals and Controlled Drug Substance requirements.
Product Leadership & Launches: Develop high performing, multi-functional teams across multiple discipline sectors and
cultural regions; build strong alliances with staff, inter-departmental resources, external experts, and executive members.
Instrumentalin delivering‘compressed’time to market product launches.
Regulatory Relationships: Participatein legislative / regulatoryforums; recognized as‘Thought Leader’regardingclean-tech
regulatory issues and policies. Established direct rapport with key decision makers in leading federal and foreign agencies;
extensive first-person relationships at EPA,FDA,DOE,EuropeanCommission,ECHAandANP (Brazil).
OUTSTANDING ACHIEVEMENTS
Amyris, Inc.:
Regulatory & Cost-sharing Collaboration: Forged regulatory strategic planning and cost-sharing collaborations with
major corporations including cosmetic manufacturers (e.g. Soliance and Firmenich), petroleum producers (e.g. Shell
and Total), diesel OEMs (e.g. Mercedes Benz, Cummins, VW, and Caterpillar), aviation industry (e.g. GE Aviation
and Parker Aerospace) and PET/Polymer manufacturers (e.g. M&G and P&G); saved up to $300K per substance.
Registrations & Certifications: Createdstrategies andsystemsto integrateregulatoryobligationsinto commercial
opportunitiesby identifyingregulatory flexibilities, allowances,and changes in policy not competitively transparent.
Achieved rapid fuels andchemicalregistration supportingearlysales leadingto revenues of$100M+ within 3 years
EPA New Chemical Registrations: Gained comprehensive EPA-TSCAregistration knowledge for fuels,
specialty chemicals, and base oils; introduced measures achieving EPAnew chemical registrations within 90 days.
Global NewChemical Registrations: Led REAChregistration(ECREACh,KoreaREAChandChinaIECSC) of fuel
and monomersubstances (fuels,chemicals,cosmetic ingredients,fragranceproducts)providinggo-to marketallowance.
FDA Food Contact Registrations& Approvals: Successfully manage(d) efforts to register chemicals / F&F;
achieve(d) Food Contact approvals (polymers, oxygen scavengers), biodiversity product approvals for organic,
Non-GMO, and sustainability management of manufacturingand CMO plant compliance.
EPA RFS II / RSB Certifications: Initiated and currently oversee efforts to attain EPARFS II and Roundtable
for Sustainable Biomaterials (RSB) certifications.
PROFESSIONAL EXPERIENCE
AMYRIS, INC.
Emeryville, CA 2008 to Present
Senior Director, Scientific and Regulatory Affairs (Global)
Deliver new product regulatory registrations, approvals, and industry validation; lead technical and regulatory research on product
ingredients to register and ensure legality of finished products in international markets. Personally oversee revenue for renewable
fuels commercialsector ($10M). Supervise 10-member cross-functionalregulatory teamin cleantech start-up environment.
Product Stewardship: Regulatory product stewardship of $100M annualindustrialbioscience product line up,60% derived
from internationalmarkets (mainly Europe and Asia). Products includerenewable fuels (ethanol, diesel, aviation turbine),base
oils / components,cosmetic ingredients,foodcontactsubstances(polymers,oxygen scavengers), and flavorsandfragrances.
Team Formation/ Start-up Environment: Formedteam to deliver results in compressedtimelines; launched approach
achieving registrations and approvals across diverseagencies includingEPA, FDAand intl. cosmetic registration boards.
Tracking / Cost Savings: Developed / implemented regulatory compliance programs and manufacturing audit programs;
currently track regulatory progress, identify cost savings, and collaborate with stakeholders to capture opportunities.
2. FERNANDO GARCIA – pg 2
(AMYRIS, INC. – continued)
Bio-jet Fuels: Lead program management of bio-jet fuels off-take agreements.
Agency Consultation: Through agency consultation, leveragedregulatory mandates into strategies resultingin rapid time to
market, reducedcertification expenditures, andachievedcompetitive product differentiation.
Accomplishments
ReductionTime to Market: Reduced time to market 3 to 6 months for new chemical and cosmetic ingredients.
EPA Consent Order & SNURS Resolutions: Through numerous TSCAPMN reviews, resolved EPA-proposed Consent
Orders and SNURS to manufacturing cost-benefit.
Brazilian MetropolitanTransit: Through OEM relations, won fuel agreements with major Brazilian metropolitan transit
authorities – 80,000 to 110,000 liters per month.
U.S. Military Agreements: Contracted fuelpurchase agreements for military evaluation and validation (Defense Logistics
Agency (DLA), NASA, US Air Force) at high price points.
Record Development,ASTM ProductStandards: DevelopedASTMInternationalproductstandards in record 18 months.
BOMBARDIER, INC.
Washington, DC 1995 to 2008
Senior Director, Governmentand Regulatory Affairs,North America,Latin America, Europe,Asia, Australia, (2000 – 2008)
Represented company as Lead Representative on U.S. and global regulatory issues and public affairs. Directed efforts to comply
with EPA, DOT, DOE and EC mandates; ensured corporate compliance with product manufacturing mandates over product
life cycle including EPA, CA Prop 65 and European RoHS, WEEE and REACh for substances utilized in manufacturing.
Federal & State Audits / Start-up Compliance: Managed federaland state enforcement audits on production operations
and product compliance. Led compliance for manufacturing start-up for environmental matters such as TSCA, EPATitle V
and State mandates, inclusive of third-party CMO operations.
Senate & CongressionalCommittees,InternationalTrade Commission: TestifiedbeforeInternationalTradeCommission,
Senate,andCongressionalcommitteesregardingproductsafety,environmentalinitiatives and commercialtradematters.
Industry Leadership / Legislative Reform: Achieved successfullegislative reform campaigns by acquiring consensus
with industry organizations and direct competitors.
European Commission,Regulatory Affairs: Served as corporate representative at European Commission on regulatory
affairs. Served on Department of Homelands Security and various state-level advisory boards.
Director,RegulatoryAffairs and Certification,North America,LatinAmerica,Europe, for BMCA (now BRP), (1995– 2000)
Established and managed division regulatory compliance program; directed development of environmentally compliant engines to
California ARB, EPAand EC exhaust emission standards. Managed $10M+ budget.
OTHER EXPERIENCE:
Engineering Manager,North America,YAMAHA CORPORATION USA, Cypress, CA
Led team in product development,test,release,andproductionof pre-productionfueleconomyandexhaustemissiontechnologies.
Research Engineer, RESEARCH COTTRELL, Irvine, CA
Performed EPAcompliancetestingof power utility andprocess facilities with fossilfuels and alternativeenergy fuels.
EDUCATION, TRAINING, and PROFESSIONAL AFFILIATIONS
BS, Mechanical Engineering, University of California at Irvine, Irvine, CA
Sustainable Futures Toxicity Training, EPA, completed
Affiliations:
Biotechnology Industry Organization (BIO), Biofuels Committee EPADifficult to Test Panel
SOCMA, Government Relations and Chemical Risk Management Committees ASTM International TF Chair
California ARB LCFS Advisory Committee Cosmetic Ingredient Review
PUBLICATIONS
“Laboratory Investigation of Advance Biased Firing for Industrial Processes”, SAE Publication, 1994
“Control of Nitrogen Oxides: Assessment of Needs and Options”, EPRI Publication, 1993
“Sub Scale Investigation of In-Furnace NOx Reduction for Industrial Applications”, Journal of Engineering Power, 1991