Nutraceutical Formulation Development and Medical Device Product Development Expert

Expertise

• Nutraceutical, Health Food, Pharmaceutical, and Medical Devices, new product development and research and discovery.
• Nutraceutical formulation development; Identifications and evaluation of new materials; process quality and improvement; quality system; and technical support.
• Dietary supplements and OTC product formulation.
• Ingredients sourcing for dietary supplements.
• Raw materials evaluation and specification development.
• Expertise in various delivery forms as Powders, tablets, two pieces hard shell capsules, soft gelatin capsules and liquids. Meal replacements, protein drinks, weight loss products, sports drinks.
• Evaluate scientific and marketing concepts and ideas and monitor market dynamics.
• Development and scientific validation of nutritional supplements products from concept to launch.
• Leading functional projects including, product development, process and technical operational improvements.
• Managing product portfolios as well as strategic planning to meet growth expectations, competitive position, and profitability.
• Chemistry of nutrition and dietary supplements, sport nutrition and protein supplements from raw materials to final product.
• Expertise in latest trends in analytical, dissolution, and disintegration testing and methodology for different delivery forms.
• Product and formulation development for innovative dietary supplements.
• Protein and carbohydrate functionality for milk shakes and meal replacements. Nutritional facts and daily value determination. Sweeteners and flavoring profiles calculation and pilots.
• Process requirements, finished goods specifications. Labels reviews to ensure legal and regulatory compliance.
• Identification and evaluation for new product and ingredient opportunities (actives and excipients), as well as product concepts. New raw materials evaluation and sourcing support. Certificate of Analyses review and specifications development. Raw materials sourcing support. Technical support for manufacturing.
• Creating of master batch records, mixing instructions and in-process manufacturing limits. Existing batch record reviews.
• Laboratory analysis of raw materials, in process and finished products. Stability, physical and analytical testing development for samples and solutions. Quantities and qualitative testing per quality standards. Stability evaluations.
• Design of experiment; data management; statistical data analysis and failure investigations, quality by design, and operational excellence.
• GMP, SOPs, ISO, EN and FDA regulations and quality standards, company policies, safety rules and regulations.
• Technology transfers from prototype to commercial stages.
• Creating documentation such as reports, flowcharts, various protocols, standard operating procedures and standard test procedures, technical descriptions, explanations of product and instructions for use.

Experience

Undisclosed Company, President and Formulation Scientist, Present

• Nutraceutical, Dietary Supplements, Functional foods, Skin care, Cosmetic and Pharmaceutical Product Development Consulting.
• Formulations, calculations, ingredients sourcing and evaluation, product and process development, samples, technical support, contract manufacturing advise.
• Solid, Semisolid and Liquid Delivery forms: Powders, Tablets, Two pieces hard shell capsules, soft gelatin capsules, gummies, liquid products and some innovative delivery forms.

Undisclosed Company, 2016 - Present

Business and Product Development, Ingredients Sourcing Consultant

• Nutraceutical, Pharma, Skin care/Cosmetics and Functional Foods products.

Research and Development Manager, OTC Products and Dietary Supplements.

• Responsible for new product formulation and process development for dietary supplements and OTC.
• Identifications of new raw materials and components to be evaluated for formulations.
• Contract customer interaction including formulation development and optimization, producing development studies and reports, batch record preparation, attending customer representatives during site visits, and trials.
• Project management, maintaining project timelines.
• Research and development activities, including sample preparations, analytical testing evaluation, and stability studies.
• Documentation development including master batch records, SOPs, testing protocols and reports.

Aenova Group, Swiss Caps USA, Miami, FL, 2014 - 2015

Product Design Manager (Formulations)

• Master formulations and product specifications development for nutritional supplements in accordance with regulations and customer specifications. Quantitative and qualitative analysis of raw materials.
• Technical support for Quality department, customer service, sourcing and production.
• Master batch records, raw material specifications, color formula calculation.
• Reviewing feasibility of all new products and scale up to manufacture.

Life Extension, Inc., Ft. Lauderdale, FL, Formulation Scientist, 2012 - 2013

• Nutraceutical research and formulations development. Dietary supplements market evaluation.
• Contract manufacturers and outsource laboratories evaluation and audit. Raw materials support.

Natures Products, Inc., Sunrise, FL, Nutraceutical Formulation Chemist, 2010 - 2012

• New formulations development and evaluations of vitamins and dietary supplements. Flavoring and sweetness profiles. Coating formulation. Evaluation and qualification of new raw materials.
• Manufacturing limits, mixing instructions, master batch records, change requests, SPECs/QQFs, Existing batch record review.
• Conducting pilots, responding to customer's complaints. Working with customers, and suppliers.

Noven Parmaceutical Inc., Miami, FL, Quality Assurance, 2009 - 2010

• Filling numerous rolls: Quality Assurance, Batch Record Reviewer and Product Release.
• Create and review documentation such as certificates of analyzes, specifications, batch records and analytical data for accuracy, completeness and compliance to all requirements and cGMP. Create investigations; corrective and prevention actions reports product release and reject decisions.
• Expiration date for new material, intermediate and finished goods release.

Cordis Corp., Johnson & Johnson Co., Miami Lakes, FL, 1996 - 2008

Research and Development and New Product Development Associate

• Polymers and other materials research, investigations and evaluation. Tests methods development. Hydrophilic and medicated coating formulation development; coating process implementing and scale up to production.
• New test methods validation. Stability testing. Process qualifications, IQ/OQ and process challenge testing.
• Responsible for equipment and analytical instruments calibration and maintenance in Product Characterization Laboratory.
• Conducted qualitative and quantitative tests per company standards, FDA submissions.

Honors & Publications

Credentials

• Coursera Certificate: Nutrition, Health, and Lifestyle: Issues and Insights.
• Six Sigma Training
• MS Office Suite including Word, Excel, Outlook, PowerPoint, Mini tab, comprehensive resource planning software as Track Wise, quality compliance software including JD Edwards, e-Synergy, Macola, Crystal Reporting and other statistical and equipment related software.

Languages

• Russian fluent (conversation, writing, reading)

Awards

• J&J Achievement Award for Hydrophilic Coating Development.
• Natures Products Best Employee Recognition Award.
• Numerous Team Excellence Awards

Patents

• Patent for Coating Formulation is pending

Education

• M.S. Material Science, Gorky engineering University, Department of Technology, Russia