Natural Products: New Product Development, Formulation and Regulatory Expert
Technical Consultant #2369
- Natural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance.
- Natural product ingredient assessments, technical review, and scientific approval.
- Provide marketing content, direction and guidance for new product launch.
- New product positioning and marketing strategy, product naming and tag line creation.
- Natural product: Product quality and marketing integrity: IP protection, regulatory compliance and quality assurance.
- Oversee all business and legal aspects of natural products development and launch; legal for reviews of trademark, patent, or other IP issues.
- Research and development of ingredients and functional food initiatives.
- Build and oversee scientific affairs, quality assurance, quality control, regulatory compliance, product development, and research and development departments: oversee and direct contract manufacturing.
Undisclosed Company, Owner and Founder, 2015 - Present
- Dietary supplement and functional food consulting organized around quality and compliance.
- Product development and innovation from ideation through commercialization.
- Ingredient scientific and technical review.
- RM-Raw Materials sourcing and supplier qualification.
- Contract manufacturing sourcing and advocacy.
- GMP compliant label development and review.
- Product claims development and substantiation gap analysis with formula revision recommendations.
- Product efficacy and safety review.
- Product financial analysis - costing, pricing, budgets, volume and inventory, and profitability.
- Marketing, positioning, branding and competitive analysis.
- Adverse Event review and Serious Adverse Event reporting.
- Quality Management System development and implementation.
- Quality assurance procedure development for finished goods.
- RM and finished product specification development.
- Sales and customer service training and support.
- Technical writing, marketing and web copy development.
Undisclosed Firm, Chief Science Officer, 2016 - 2017
- Accountable to build and oversee scientific affairs, quality assurance, quality control, regulatory compliance, product development, and research and development departments, overseeing and directing:
- Contract manufacturing; source and vet new raw materials; develop vendor relationships and negotiate supply agreements;
- Develop SOPs and protocols for GMP compliance; conduct GMP audits;
- Develop ingredient specifications and create finished product spec packets;
- Develop new products and revise existing formulas;
- Oversee new ingredient qualification and finished product testing;
- Create claims substantiation dossiers and white papers;
- Contribute to clinical trial design; oversee product licensing with Health Canada.
- Build scientific affairs, QA/QC, (Quality Assurance and Quality Compliance) regulatory affairs, product development and research and development from the ground up.
- Champion full GMP compliance through developing SOPs for all departments.
- Innovate, design and develop new product launches from ideation through manufacturing.
- Develop GMP compliant labels for new and existing products.
- Intellectual property development, including patented formulas and trademark names.
- Provide leadership and direction around product claims substantiation.
Creator and Developer (new and upgraded) firm's brand products:
- GI Health Formula
- Mood Balance Formula
Progressive Laboratories, Irving, TX, Director of Product Innovation, 2013 - 2015
- Accountable for innovation in new product development and formulation; brand identity distinction and development; seek out exclusive opportunities to launch unique new products and or delivery systems.
- Develop and implement new raw material qualification protocols; provide leadership around quality assurance and regulatory compliance throughout product development process.
- Oversee project management from ideation through manufacturing; vet new product opportunities through scientific, technical, safety, and legal review.
- Develop marketing, sales, and educational materials for new product launch; speak at trade shows and conventions.
- Innovate, design, and develop new product launches from ideation through manufacturing.
- Guide executive management in marketing strategy, product positioning, claim substantiation, and brand identity development.
- Direct purchasing department regarding new product launch forecasting and initial PO estimation.
- Label development and review.
- Intellectual property development and protection.
- Product naming and tag line creation.
- Develop and deliver educational webinars for licensed health care professionals.
Creator and Developer
- Resilience® line of Progressive Labs products
- Daily Resilience® (encapsulated and stick pack versions)
- Cognitive Resilience®
- Adrenal Resilience®
- Antioxidant Resilience®
- Hair, Skin, and Nail Resilience®
- Men's Resilience®
- Women's Resilience®
- Liver Resilience®
- Cardio Fit™
Life Extension, Fort Lauderdale, FL, Senior Research and Development Scientist, 2010 - 2013
- New product development and formulation; vet new product opportunities.
- Product navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance.
- New ingredient assessment, technical review, and scientific approval.
- Provide marketing content, direction and guidance for new product launch magazine articles and ads.
- Oversee all business and legal aspects of product development and launch; partner with legal for reviews of trademark, patent, or other IP issues.
- Collaborate with quality assurance around raw material testing strategy and qualification.
- Innovate, design, and develop new product launches from ideation to manufacturing.
- Guide and oversee research and development for ingredient research and functional food initiatives at universities.
- Guide and oversee ingredient and product clinical research and claim substantiation.
- Direct purchasing group regarding new product launch forecasting and initial PO estimation.
- Direct magazine Chief Editor regarding new product positioning and marketing strategy.
- Product naming and tag line creation.
New Product Development
- Liver Efficiency Formula
- Advanced Natural Sex for Women®
- Advanced Natural Sex for Women® 50+
- Adrenal Energy Formula
- Bio-Collagen with Patented UC-II®
- Cardio Peak™ with Standardized Hawthorn and Arjuna
- Extraordinary Enzymes
- Black Cumin Seed Oil
- Black Cumin Seed Oil with Bio-Curcumin®
- Immune Modulator with Tinofend®
- GlycemicPro™ Transglucosidase
Pure Essence Labs, Las Vegas, NV, Director of Product and Trainer, 2009 - 2010
- Accountable for innovating, developing and delivering new products including material and manufacturing sourcing, marketing collateral, technical literature and documentation.
- Provide delivery chain support; training and education for health care practitioners, inside and outside sales, customer service representatives, retail sales force and consumers.
- Manage Quality Assurance and Regulatory Compliance.
- Innovate, design and manage new product launch from concept through cGMP manufacturing.
- Spearhead initiative to create complete technical product formula bibliographies.
- Initiate, direct and deliver an ingredient library specific to consumer and retailer inquires.
- Design and direct label information, marketing and web copy audits. Institute corrections through policy and procedure development as necessary.
- Increase Prop 65 product compliance through special project initiative.
- Direct and manage product audits; initiate purity changes to align with intended formulation
- Contribute to the formulation, development and launch of 4 new products over six months.
- From concept, create over 20 product training presentations.
Vaxa International, Tampa, FL, Chief Medical Officer and Chief Science Officer, 2008 - 2009
- Accountable for product education and training, technical support: practitioners, inside - outside sales force, and customer service.
- Company spokesperson; national and local radio program guest; write technical copy and feature articles for website and marketing pieces.
- Manage Quality Assurance and Regulatory Compliance: Design; develop and build an in-house library of CofAs for all product ingredients.
- Initiate a technical specification library for all products and ingredients.
- Provide accurate, and relevant scientific rationale and validation for nutraceutical ingredients.
- Research Materia Medica: Deliver accurate and relevant rationale for homeopathic and nutracetucial ingredients.
- Direct and manage product audits; correct stability issues with existing products.
- Design and direct labeling, marketing and web copy audits.
- Institute corrections through policy and procedure development.
- Provide guidance in effectively responding to FDA audits; provide accurate and relevant information to correct label discrepancies.
- Led over 40 training sessions per month for health care practitioners, inside and outside sales, customer service and retail sales representatives, training over 500 people.
- Conceive, design and deliver a product training manual library.
- Regular guest on WHNZ Consumer Education Network radio program, Tampa, FL and on Community Talk AM KTLR.
Sea Change New York, Manhattan, NY,Naturopathic Physician, 2006 - 2007
- Private practice
The Chopra Center for Wellbeing, Carlsbad, CA, Naturopathic Doctor and Director, 2004 - 2006
- Accountable for patient consulting, launch and directing of the Practitioner Affiliate Program providing Ayurvedic training for health care practitioners.
- Center spokesperson responsible for public relations in person, marketing and web copy.
- Lecturing to Chopra Center and La Costa Resort guests.
Natural Alternatives International, San Marcos, CA, Research Scientist, 2002 - 2005
- Accountable for innovating, developing and delivering new products.
- Material sourcing, marketing collateral, technical and scientific literature and documentation.
- Delivery chain support; training and development of inside and outside sales, customer service representatives, and retail sales force.
- Research and develop formulas, structure and function claims, scientific validation, develop label copy and bibliography materials.
- Manage product piloting and post formulation production process.
- Lead formulator for "Chopra Center Essentials" nutritional supplements.
- Medical writer and managing editor for the "Chopra Center Essentials" magalog.
- Project manager and call center staff trainer for the Chopra Center and Jennifer O'Neill brand products.
- International corporate speaker for Nikken nutritional supplements.
Honors & Publications
- Health Care Practitioner Trainer
- Excellerated Business Schools, San Diego, CA (Money)
- Mission Control Productivity and Accomplishment graduate
- Instructor: Curriculum for Living, Communication Courses
Academic and Professional Affiliations
- American Association of Naturopathic Physicians
- Children's Multi-Vitamin - Supply Side CPG Editor's Choice Awards
- Numerous naturopathic medicines
- N.D. Naturopathic Medicine, National College-Naturopathic Medicine, Portland, OR
- B.G.S. Biomedical Graduate Studies, University: Pittsburg State University, Pittsburg, KS