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MICHAEL FANTUZZI is a dedicated professional with extensive R&D experience and expertise in all phases of product development lifecycle. Notable success in reformulatin g existing products to improve yield and ensure compliance with regulatory guide lines, customer specifications, and GMPs. Resourceful and self-directed researcher who approaches challenges with creativi ty and innovation, while ensuring all actions comply with appropriate regulation s / standards.
MICHAEL FANTUZZI is a dedicated professional with extensive R&D experience and expertise in all phases of product development lifecycle. Notable success in reformulatin g existing products to improve yield and ensure compliance with regulatory guide lines, customer specifications, and GMPs. Resourceful and self-directed researcher who approaches challenges with creativi ty and innovation, while ensuring all actions comply with appropriate regulation s / standards.
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MICHAEL FANTUZZI is a dedicated professional with extensive R&D experience and expertise in all phases of product development lifecycle. Notable success in reformulatin g existing products to improve yield and ensure compliance with regulatory guide lines, customer specifications, and GMPs. Resourceful and self-directed researcher who approaches challenges with creativi ty and innovation, while ensuring all actions comply with appropriate regulation s / standards.
Hak Cipta:
Attribution Non-Commercial (BY-NC)
Format Tersedia
Unduh sebagai TXT, PDF, TXT atau baca online dari Scribd
1421 Rock Glen Avenue, Apt. C * Glendale, CA 91205
213.910.6838 * michaelfantuzzi@sbcglobal.net
R&D PROFESSIONAL Formulation Chemistry | Product Development | Diagnostic Research
Accomplished, dedicated professional with extensive R&D experience and expertise
in all phases of product development lifecycle. Notable success in reformulatin g existing products to improve yield and ensure compliance with regulatory guide lines, customer specifications, and GMPs. Highly knowledgeable of cellular/molec ular biology, pharmaceutics, anatomy/histology, and biostatistics; proficient wi th numerous lab techniques, including gel electrophoresis, ELISA, HPLC, GC, and assay development; also experienced with wet chemistry techniques. Maintain awa reness of industry changes and developments; perform literature searches to dete rmine 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 creativi ty and innovation, while ensuring all actions comply with appropriate regulation s/standards. Recognized for ability to make intellectual contributions to curren t research activities and contribute significantly to design of experiments and new techniques. Valued and respected associate known for strong attention to det ail, 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 supplemen t industry Formulation Chemist/R&D Manager Direct research and development activities involved in formulation of nutritiona l supplements and incorporation of ingredients into soft gel capsules. Ensure ma terials meet customer specifications, as well as requirements for potency, stabi lity, and ease of manufacturing. Key functions include: Product Development and Testing: * Evaluate and approve raw materials for conformance to regulatory guidelines an d ease of use specifications; draft specifications for each approved material. * Approve batch tickets for formulations and gel batches to ensure proper formul ation, adequate concentrations, appropriate fill weights/control limits, and oth er physical properties in conformance with customer requirements. * Write master and working formulas, including manufacturing instructions and co ntrols; create nutritional facts panels and product specification sheets for cus tomer approval. * Create and perform pilot projections for new products and supervise scale-up r uns. * Establish dosage forms with improved bioavailability and other functional adap tations. * Prepare certificates of analysis for products; communicate required parameters and assay methods for each marker compound and ingredient. * Hold 6 U.S. and foreign patents for improved formulations/dosage forms, which increased bioavailability/blood levels 300 to 800%. Quality Assurance / Quality Control: * Advise QC/QA groups on matters concerning OOS materials/assay results, investi gation and remediation of customer complaints, and regulatory requirements. * Identify and report trouble spots in product manufacturing/testing to detect d eficiencies in raw materials. ...Continued... ...Page 2 of 3... MICHAEL FANTUZZI 213.910.6838 * michaelfantuzzi@sbcglobal.net
PROFESSIONAL RESEARCH EXPERIENCE (CONTINUED)
SOFT GEL TECHNOLOGIES, INC. * Continued Lab Management / Inter-departmental Collaboration: * Supervise, mentor, and train team of six chemists/research technicians. * Participate in production meetings to minimize or resolve production issues. * Address technical questions about finished products and raw materials for sale speople, customers, and other departments within company. * Communicate with contracted laboratories and continuously evaluate performance . * Interface with patent attorneys regarding new inventions for patent applicatio ns; facilitate understanding of key innovations and other potential uses for pro ducts 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 c ells, and other cell lines. * Combined cultures from patients' cells to obtain solid pieces of skin used for grafting. * Supported initiation and maintenance of cultures; maintained cell library in l iquid nitrogen. * Observed and assisted during surgeries; attended patient follow-ups to evaluat e success of grafts. 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 mu ltiple diseases and disorders. * Radio-labeled antibodies, antigens, and derivatives with 125I for use in radio immunoassay test kits. * Separated and purified products by column chromatography to achieve desired ac tivity of radioactive constituents. * Compounded buffers and diluents for kits while ensuring compliance with GMP gu idelines. 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 dir ection of senior researcher to support cancer diagnoses and treatment. * Performed tissue cultures, including primary and secondary cultures of tumor c ells. * Tested drug-sensitivity in live tumor cells. * Utilized hormone-receptor assays of cytosol prepared from the tumors and ascit es. * Isolated and purified super-oxide dismutase from erythrocytes. * Maintained established cell lines used in studies and as controls. * Formulated various media for cultures, drugs, and materials needed for assays.
...Continued... ...Page 3 of 3... MICHAEL FANTUZZI 213.910.6838 * michaelfantuzzi@sbcglobal.net
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. * Processed blood and urine chemistries. * Monitored quality control of specimens and test results. * Maintained and calibrated equipment to guarantee optimal functioning and ensur e reliability of results. Additionally, completed internships toward Pharm.D. at local pharmacy and multip le 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 const ruction, 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 Amer ican Association for the Advancement of Science