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.
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