Senior Chemist/ R&D Manager

MICHAEL FANTUZZI

**** **** **** ****** • Glendale, CA 91205

213-***-**** • ***************@*****.***

R&D PROFESSIONAL

Formulation Chemistry | Product/Process Development | Quality Control/Assurance

Accomplished, dedicated professional with extensive R&D and Quality Control experience as well as expertise in all phases of product and process development, manufacture, and the lifecycle of raw materials and finished products. Notable success in reformulating and improving the manufacture of existing products to increase yield, ease of manufacture, reduce costs, ensure product stability for desired shelflife, and compliance with all regulatory guidelines, GMPs, and customer specifications. Highly knowledgeable of FDA regulations and GMPs for dietary supplements (including the new GMPs recently put into effect), OTCs, and consumer products.

Considerable success developing new, innovative products and dosage forms in dietary supplements, OTC products, lotions and creams, breath fresheners, toothpaste, denture adhesive, etc.

Proficient with numerous lab procedures, including HPLC, GC, clinical analysis, gel electrophoresis, ELISA, blood group and clotting factor assays, wet chemistry techniques, etc.; also experienced with assay development. Maintain awareness of industry changes and developments; perform literature searches to determine any new, beneficial applications. Develop, design, and execute experiments in compliance with GLPs, QC/QA requirements, and other laboratory protocols.

Resourceful and self-directed researcher who approaches challenges with creativity and innovation, while ensuring all actions comply with appropriate regulations/standards. Recognized for ability to make intellectual contributions to current research activities and contribute significantly to design of experiments and new techniques. Valued and respected associate known for strong attention to detail, superior work ethic, and exemplary performance.

PROFESSIONAL RESEARCH EXPERIENCE

SOFT GEL TECHNOLOGIES, INC., Los Angeles, CA • 1999-2009

Contract manufacturer of soft gelatin capsules exclusively for dietary supplement industry

Formulation Chemist/R&D Manager

Direct research and development activities involved in formulation and manufacture of nutritional supplements consisting of oil-based suspensions and emulsions that were incorporated into soft gel capsules. Ensure materials meet customer specifications, as well as requirements for potency, stability, and ease of manufacturing. Key functions include:

Formulation and Manufacturing:

• Manage R&D department with 6 chemists/techs, costing estimate supervisor and clerks.

• Formulate new products according to customers’ specifications and re-formulate existing products to eliminate low yield, assay problems, or manufacturing difficulties.

• Write all master formulas and manufacturing instructions/parameters.

• Research new manufacturing methods, new equipment, and improvement/ease of manufacturing by formulation/equipment/process changes. Implement technical transfer when applicable.

• Examine new materials/processes/equipment brought by salespeople/agents/customers to ascertain if they can be used in existing or new products, as well as to determine if they will cause any manufacturing/stability/assay difficulties.

• Troubleshoot formulas and manufacturing procedures to simplify manufacturing, increase yield, and control costs.

• Plan and supervise pilot projects and scale-up runs.

• Attend meetings to determine production problems and how to eliminate or reduce them.

• Give technical advice where needed.

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MICHAEL FANTUZZI

213-***-**** • ***************@*****.***

PROFESSIONAL RESEARCH EXPERIENCE (CONTINUED)

SOFT GEL TECHNOLOGIES, INC ( CONTINUED):

Quality Assurance / Quality Control:

• Act as de facto supervisor and advise QC/QA groups on matters concerning OOS materials/deviation reports, deciding when and if out-of-spec materials can be used in products with re-formulation or changes in manufacturing procedures, deciding if assay methods are appropriate, which outside labs could be used for certain assays, and causes of unacceptable assay results when obtained, as well as how they could be overcome/avoided in the future.

• Writing and maintaining Certificates of Analysis, SOPs, raw material specifications, product specifications, nutritional facts panels, importation/exportation documentation for customers, supplier evaluation questionnaires, and any other regulatory documents, as needed.

• Understanding and implementation of the new FDA regulations for dietary supplements, as well as DSHEA , Prop 65., and any industry recommendations/guidelines, keeping up to date on compendial matters for testing materials and finished products as well as stability issues and procedures.

• Responsible to assist QA with investigation and remediation of customer complaints, much of the time finding and reporting the root causes and possible remedies of any product failures or abnormalities.

• Manage continuous improvement projects; identify and report trouble spots in product manufacturing/testing, detect deficiencies in raw materials, manufacturing processes, storage and handling of products.

• Evaluation of outside contract laboratories used for testing; deciding which assays each was capable of handling, what their strengths and weaknesses were, and assisting in correcting any deficiencies in assays with unfavorable results and finding remedies/other test methods to correct those deficiencies.

• Attend multi-departmental meetings and advise on quality issues as well as R&D and product development matters.

• Major company asset for any scientific/technical matters, answering questions for other company departments, salespeople, marketing, customers, and patent attorneys. Attending meetings with suppliers of new materials to determine what uses they may have for products/manufacturing, and assay or manufacturing difficulties that may occur with the use of the materials.

• Writing of technical reports regarding any quality, manufacturing or R&D matter for use by administration and owner of company.

Product Development and Testing:

• Evaluate, test, and approve raw materials for conformance to purity, regulatory guidelines, safety, and ease of use; draft specifications for each approved material and maintain specifications database.

• Approve batch tickets for formulations and gel batches to ensure proper formulation, adequate concentrations, appropriate fill weights/control limits, and other physical properties in conformance with customer requirements/GMPs, or special manufacturing considerations.

• Write master and working formulas, including manufacturing instructions and controls; create nutritional facts panels, import/export documentation and product specification sheets for customer approval.

• Create and perform pilot projects for new products and supervise scale-up runs.

• Develop new/innovative dosage forms for improved bioavailability and other functional adaptations.

• Prepare certificates of analysis for products; communicate required parameters and assay methods for each marker compound and ingredient.

• Testing of raw materials and finished products; actives and physical characteristics.

• Inventor on 6 U.S. and foreign patents for improved formulations/dosage forms, which increased bioavailability/blood levels from 300 to 800% in clinical tests.

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MICHAEL FANTUZZI

213-***-**** • ***************@*****.***

PROFESSIONAL RESEARCH EXPERIENCE (CONTINUED)

SOFT GEL TECHNOLOGIES, INC ( CONTINUED):

Lab Management / Inter-departmental Collaboration:

• Supervise, mentor, and train team of six chemists/research technicians, cost estimators, and clerks in R&D as well as QC and QA..

• Participate in production meetings to minimize or resolve production/quality issues.

• Address technical questions about finished products and raw materials for salespeople, customers, and other departments within company.

• Communicate with contracted laboratories and continuously evaluate performance.

• Interface with patent attorneys regarding new inventions for patent applications; facilitate understanding of key innovations and other potential uses for products in order to create comprehensive patent filings.

THE FOUNDATION FOR BURN RESEARCH, Sherman Oaks, CA • 1989-1991

Organization providing research, support services, and reconstructive treatment to burn patients

Research Associate

Engaged in investigations and experiments to advance field of burn treatment and achieve greater recipient acceptance of skin grafts. Oversaw all lab operations, including maintaining patient files and treatment records.

• Prepared primary and secondary tissue cultures of keratinocytes, mesenchymal cells, and other cell lines.

• Combined cultures from patients’ cells to obtain solid pieces of skin used for grafting onto burn patients.

• Initiated and sub-cultured cell cultures; maintained cell library in liquid nitrogen.

• Observed and assisted during surgeries; performed patient follow-ups to evaluate success of grafts.

• Researched new technologies for applicability in our work, implementing any that seemed feasible.

• Managed all aspects of the laboratory.

DIAGNOSTIC PRODUCTS CORPORATION, Los Angeles, CA • 1988-1989

Worldwide provider of immunodiagnostic systems and reagents

Chemist

Conducted experiments and investigations vital to detection and management of multiple diseases and disorders.

• Radio-labeled antibodies, antigens, and derivatives with 125I for use in radioimmunoassay test kits.

• Separated and purified products by column chromatography then diluted to achieve desired activity of radioactive constituents.

• Compounded buffers and diluents for kits while ensuring compliance with GMP guidelines.

• Bottled and lyophilized all kit constituents after completion of compounding.

SOUTHERN CALIFORNIA CANCER CENTER, Los Angeles, CA • 1982-1986

Recognized leader in cancer prevention, diagnosis, and treatment

Research Assistant

Conducted broad range of laboratory testing, experiments, and analyses under direction of senior researcher to support cancer diagnoses and treatment.

• Tissue culture, including primary and secondary cultures of tumor cells; maintained established cell lines used in studies and as controls.

• Injected rats with cancer cells and later sacrificed to obtain tumors; removed organs to obtain hormones for research purposes.

• Performed drug-sensitivity tests in live tumor cells.

• Performed hormone-receptor assays of cytosol prepared from the tumors and ascites of patients.

• Isolated and purified super-oxide dismutase from erythrocytes.

• Formulated various media for cultures, drugs, and materials needed for assays.

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MICHAEL FANTUZZI

213-***-**** • ***************@*****.***

PROFESSIONAL RESEARCH EXPERIENCE (CONTINUED)

BICON LABORATORIES, INC., Pasadena, CA • 1979-1982; 1985-1986

Clinical reference laboratory

Laboratory Technician / Shift Supervisor

• Performed toxicology screening of blood, urine, and gastric contents.

• Analyzed blood and urine chemistries by RIA, automated assay equipment, “wet” chemistry methods, gel electrophoresis, etc.

• Performed blood clotting factor assays with fibrometer and blood group analysis.

• Monitored quality control of specimens and test results.

• Maintained and calibrated equipment to guarantee optimal functioning and ensure reliability of results.

Additionally, completed internships toward Pharm.D. at local pharmacy and multiple departments of LAC/USC County General Hospital.

ADDITIONAL PROFESSIONAL EXPERIENCE

INDEPENDENT CONTRACTOR, Los Angeles, CA • 1991-1999

Consultant/Contractor

Selected by numerous construction companies and private clients to perform construction, maintenance, and repair work. Provided consultations on feasibility of projects and coached builders on regulatory issues involving chemical materials.

EDUCATION & PROFESSIONAL AFFILIATIONS

Bachelor of Science in Biochemistry, minor in Microbiology

California State University – Los Angeles, CA

Associate of Arts in Chemistry, minor in Mathematics

Pasadena City College – Pasadena, CA

Completed with GPA of 3.97/4.0

Completed 5 semesters (64 credits) toward Pharm.D.

USC School of Pharmacy – Los Angeles, CA

Member of American Chemical Society, American Society of Pharmacognosy, and American Association for the Advancement of Science

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