Expert Details
Fermentation, Scientific and Regulatory Affairs
ID: 739516
Colorado, USA
Her specialties include Product Innovation and Formulation, CPG Application Testing COGS and Process Improvement, Food Science, Safety and Quality, Regulatory Strategy, Claims Substantiation, Program Management, External Partnership Management, and Intellectual Property Strategy.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1998 | Degree: PhD | Subject: Molecular Biology | Institution: University of Oregon |
| Year: 1983 | Degree: BS | Subject: Medical Technology | Institution: University of New Hampshire |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2020 to 2022 | Employer: Geltor - Biotechnology Company | Title: Vice President | Department: Commercial Development and Regulatory Affairs |
Responsibilities:Led product development of high impact protein ingredients for Food & Nutrition and Beauty & Personal Care markets. Fully accountable for the success of: Ingredient claims substantiation via a combination of in-vitro, ex-vivo and clinical trials. Regulatory approval for a novel food ingredient. Successfully completed a GRAS self-assessment and an enhanced dossier for FDA GRAS, including a human pharmacokinetic study. Regulatory plan enabling import of Geltor cosmetic ingredients into China under new NMPA regulations. Formulation in CPG applications and development of finished food and cosmetic product prototypes. Combined in-house expertise with external contract research to develop prototypes for marketing and business development. Business Development support in partnership with General Managers for Food/Nutrition and Personal Care business units. |
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| Years | Employer | Title | Department |
| Years: 2019 to 2020 | Employer: MBP Titan (Subsidiary of Intrexon, Corp.) | Title: Vice President | Department: Research and Development |
Responsibilities:Technical and cultural leadership of the Industrial Products Division. Led a team of 100+ scientists and engineers. Gas-to-liquid fermentation technology produced animal feed protein and chemistry polymer precursors from methane and engineered methanotroph bacteria. Transitioned of the organization from a research-oriented culture to a commercial team with clearly defined timelines, commercial milestones and budgets. Integrated workflows across all functions to demonstrate a technically viable manufacturing process at 500 liter pilot scale in house. Led a matrix organization comprised of data science & computational biology, strain engineering, molecular biology & bioinformatics, analytical chemistry, robotics and high throughput screening, fermentation and process engineering. Ensured FTO for commercial process in collaboration with Legal counsel. Company closed due to COVID pandemic. |
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| Years | Employer | Title | Department |
| Years: 2017 to 2019 | Employer: Kerry Ingredients | Title: Director, Product Research, Development and Applications | Department: |
Responsibilities:Strategic leadership of Clean Label Food Preservative & Fermentation team.Global Food Ingredient Company. Developed ingredients replacing chemical food preservatives while protecting consumers from pathogens such as Salmonella, Listeria, E. coli and C. botulinum. Formulation applications included meat, dairy, breads, ready-meals, cheeses, sauces and beverages, each with specific processing, organoleptic and food safety requirements. Managed product stability testing, preliminary specification setting and refinement across multiple manufacturing locations and processes. Coordinated food safety trials in LATAM, Europe and Asia with regional-specific applications. Delivered improvements in manufacturing processes through use of techno-economic models to identify key process cost drivers. COGS analysis with Finance to drive toward desired margin. |
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| Years | Employer | Title | Department |
| Years: 2010 to 2016 | Employer: Synthetic Genomics | Title: Director - Nutritional Product Development | Department: |
Responsibilities:Led development of nutritional protein and oil ingredients from heterotrophic algae.Synthetic biology biotechnology company. Converted research laboratory facility to cGMP pilot manufacturing facility to support preparation of customer samples that were safe for consumptive evaluation. As part of comprehensive plan to achieve FDA GRAS status for the novel ingredient, demonstrated successful Acute Toxicology safety testing. Full plan through sub-chronic rat studies developed. Achieved economic targets and quality metrics competitive with soy protein benchmark product and demonstrated reproducible process within specification in 3 different pilot scale facilities. Developed a competitive manufacturing process for omega-3 DHA within 2 years from concept to commercial licensing to Archer Daniels Midland. Established work plan and milestones for program with $8M budget and 10 direct and 12 indirect reports. Achieved estimated 25-30% reduction in COGS compared to market incumbent based on pilot studies. Synchronized measurement of milestones across organizations to trigger milestone payments from ADM to SGI. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2010 | Employer: Kuehnle Agrosystems, LLC | Title: Head of Research & Development | Department: |
Responsibilities:As the Head of R&D at this private algae biotechnology company, Expert developed novel genetic tools for marine algae biotechnology.Products included nutritional ingredients and vaccine antigens for point-of-care medical testing. |
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Career Accomplishments
| Associations / Societies |
|---|
| Member - Association of Food and Drug Officials (AFDO) Member - American Society for Quality (#65612903) Member - Institute of Food Technologists (#00819057) |
| Licenses / Certifications |
|---|
| Certified Food Scientist (Institute of Food Technologists - Certificate #4372) Certified Preventive Controls Qualified Individual (PCQI) |
Fields of Expertise
fermentation technology, fermentation scale-up, food preservatives, synthetic biology, regulatory affairs, FDA GRAS, product claims substantiation, nutritional ingredients, nutritional protein, nutritional oil, food science, ingredient, food ingredient, ingredient commercialization, program management, product innovation, product formulation, regulatory strategy