Natural Products: New Product Development, Formulation and Regulatory Expert

Technical Consultant #2369


Expertise

  • 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.

Experience

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:

  • Release™
  • 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™
  • Opti-Pedi™Multi-Vitamin

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

Credentials

  • 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

Awards

  • Children's Multi-Vitamin - Supply Side CPG Editor's Choice Awards

Patents

  • Numerous naturopathic medicines

Education

  • N.D. Naturopathic Medicine, National College-Naturopathic Medicine, Portland, OR
  • B.G.S. Biomedical Graduate Studies, University: Pittsburg State University, Pittsburg, KS
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