Quality Control Management

MATTHEW AVIOLI

* **** ***** ****, **********, NJ 07960

781-***-**** (Cell) Email: *************@*****.***

Summary Pharmaceutical management M.B.A. graduate seeking scientific management role in the biotech/pharmaceutical/cosmetic/chemical industry. 7+ years laboratory experience and leadership skills. Work experience in analytical chemical and PCR diagnostics quality control, and human skin culture research in the pharmaceutical/cosmetic industry.

Most Recent Roche Molecular Systems, Branchburg NJ (July 2005-January 2012)

Position Scientist II, Quality Operations

Responsible for quality control testing in highly automated laboratory on molecular diagnostic kits. Conduct assays using real-time PCR thermocycler technology and analytical chemistry instruments. Conduct testing on raw, pre-fill and vial components of kits.

Regular duties include:

• Use of HPLC, AA, FT-IR, GC, UV/VIS, scintillation counter, conductivity meter, refractometer, hematology counter, titrations, fluorospectrometer, differential scanning colorimeter, and southern blot to conduct assays.

• QC testing of Roche diagnostic products including Cobas Amplicor,

Taqman, AmpliPrep and other thermocyclers.

• Purchase of laboratory materials for 18 person organization; using SAP for checking inventory and status: documentation of lab results into LIMS; training of new employees on test procedures and LIMS software; and supervision of lab equipment maintenance. Also trained in radiation safety and hazmat regulations.

• Principal member of validation team that created new UATR attachment for

FT-IR device, including required spectrum library, software test, and SOP

proposal for presentation to the Roche change control board.

• Testing to support FDA process validation of new Roche production facility.

• Expert in FDA and ISO regulations, as well as GLP and GMP techniques.

• Principal member of team that created a raw material sampling room.

Principal member of internal audit team that conducts monthly audits all of Operation Labs as well as maintain compliance within the QO Chemistry group. Experience in implementing and documenting CAPA/OOS/IRs.

Completed numerous MDCR/CCR’s for the revising of SOP’s and DFT’s.

Education Fairleigh Dickinson University, Florham Park, NJ (2007 – 2011)

Masters of Business Administration, Concentration in Pharmaceutical Management GPA: 3.6

Brandeis University, Waltham, MA (Dual Major) (2001-2005)

Bachelor of Science, Biology, May 2005

Bachelor of Science, Anthropology, May 2005

Academic Biology: Extensive college experience with research equipment including

Training PCR machines, centrifuges, and mechanical pipettes for cell, molecular, and

genetics research. Conducted lab work in genetics of drosophila and

bacterial cultures, including work focusing on DNA and cell components.

Course concentration in physiology, neuroscience, cell biology, and ecology.

Anthropology: Experienced in study of biological anthropology, with strong

training in evolution, archaeology, Mesoamerican civilizations, and

anthropological methodology. Interest in psychological anthropology.

Pharmaceutical Management: Academic training in pharmaceutical marketing, pharmaceutical quality and R&D operations, supply chain management, general marketing, economics, finance, statistics, information systems, and entrepreneurship courses. Capstone involved providing a business management plan to Ezose Sciences, an emerging CRO.

Prior Avon Products, Suffern NY (Summer 2004)

Employment Research and Development Intern, Cell Biology In Vitro Toxicology Experience

Completed tests of new products using SDS page gel electrophoresis,

spectrophotometer and phosphor-imager readings, and western blot staining

techniques using antibodies.

Wrote Avon standard operating procedures for SDS page gel electrophoresis,

for western blotting, and for BCA protein assay.

Assisted with live tissue sample maintenance and testing in support of Avon

senior research scientists. Conducted lab experiments independently, reported

progress on product testing to senior management.

Environmental Education Center, Somerset County, NJ (Summer 2002)

Assistant Naturalist (Full-time)

Paid intern at regional center for community education and research, focused

on preservation of New Jersey’s interior wetlands and habitats. Personal duties

included supervising day programs in the Great Swamp National Wildlife

Preserve; providing guidance to children interested in ecology; creating and

maintaining center’s nature exhibits; and assisting in editing center’s

periodic environmental education newsletter.

American Museum of Natural History, New York City (Part Time 1999-2001)

Volunteer Guide in the Museum's 'Natural Science Center'

Worked in natural habitat center in prestigious national Museum, specializing

in environmental education programs for children on plants and animals

indigenous to New York City nature environments. Personal responsibilities

included guiding children through exhibits; presenting exhibited animals and

plants; and keeping nature exhibits well organized and updated.

College Officer of Sigma Alpha Mu Fraternity at Brandeis University

Activities Member of Brandeis University Ski Team

Honors ‘Governor’s Scholar’, State of New Jersey, Environmental Studies, 2000

Additional

Skills Microsoft Office Suite (Word, Excel, Powerpoint, Outlook)

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