Quality Control Customer Service

Michael J. Ciocci, Ph.D.

*** *. ******* ***.

Royersford, PA 19468

610-***-**** (H)

610-***-**** (C)

Email: ********@*****.***

Education: Ph.D. in Biochemistry, University of Maryland at College Park (awarded 2/96)

B.S. in Biology, State University of New York at Albany (awarded 5/86)

Skills:

• Coauthor of two patent applications for particle development for cell capture and protein purification.

• Experienced in lateral flow assay process transfer, validation, device assembly

• Years of experience in conjugation of both proteins and nano/microparticles

• Over ten years of cGMP experience, including six years developing QC methods.

• Eight years of supervisory experience, including two years supervision of a Quality Control department.

• Expert in chromatography instrumentation (AKTA, Waters, Agilent, Rainin, Gilson) and techniques for the purification and analysis of large molecules (proteins) and small molecules.

• Expert in Immunology assays, including ELISA, RID, Immunoelectrophoresis, Western Blot, and cell based/fluorescence assays.

• Molecular Biology technical expertise, including cloning, subcloning, restriction digestion, ligation, transformation, and expression system development

• Customer service and Technical service experience with a reagent company.

• Years of experience in wet chemistry techniques (including identity and concentration assays, HPLC).

• Experience in electrophoretic techniques, including SDS-PAGE, IEF, 2D, and capillary electrophoresis.

• Experience in writing SOPs, method development reports, method and process validation protocols and validation summary reports.

• Experience in Tech Transfer of both processes and analytical methods as part of FDA submissions.

• Have worked in an FDA regulated environment for more than five years and have developed and validated a number of assays under FDA diagnostic device guidelines.

• Trained and experienced in various Quality policies and Laboratory Safety.

• Six Sigma Green Belt training.

• Experience in managing cross-functional teams and project management.

• Over twenty years of college teaching experience.

Experience: 08/01/2011 to Present, Consultant, Seneb Biosciences, Doylestown, PA

Responsible for purification and analysis of large molecules both modified and unmodified for use in pharmaceutical testing. Purification techniques include IEX, SEC, metal affinity, dye affinity, hydroxyapatite, HIC. Conduct analytical testing on purified material(s) including BCA, SDS-PAGE, and Endotoxin (LAL) assays.

04/01/2009 to Present, VP Manufacturing and Quality Control, Russell Biotech, Doylestown, PA

Responsible for the development of proprietary magnetic particles for protein isolation and purification, cell isolation and purging, and immunodiagnostic assays. Developed conjugation methods for nanoparticles with proteins and small molecules. Developed protein conjugation protocols for antibodies to small molecules, antibodies and other proteins to fluorescent dyes and proteins. Developed quality control assays for manufactured particle testing. Manage product and supply inventories. Develop and manage timelines for product development. Supervise company employees. Consult with, supervise, and assist in assay development for liver disease biomarkers.

12/30/2008 to 03/31/2009, Consultant, Russell Biotech, Doylestown, PA

Provide analytical method development assistance, experimental design, and document writing (SOPs, Protocols and Reports, Patents) for research in particle development for capturing rare and specific cell populations, and for protein purification.

9/17/2007 to 12/18/2008, Senior Process Improvement Scientist, OraSure Technologies, Bethlehem, PA

Process Improvement design, validation, and implementation of processes used for lateral flow assay development in support of HCV lateral flow assay FDA 510K submission. Process Qualification of AKTA FPLC system and Process Validation of purification processes. Lateral flow assay assembly and component production experience. Test Method design and validation. Tech transfer of processes to Manufacturing department for production. Process Improvement and Operations support, including non conformance investigations and long term lateral flow assay issue investigations.

3/2005 to 9/2007, Principal Scientist, Product Support/Donor Screening Ortho Clinical Diagnostics, Raritan, NJ

Provide support to AIDS/HEP Operations group in terms of antibody production troubleshooting, assay manufacturing, and QC issues. Six Sigma Green Belt certification training.

9/1999-1/2005 Senior Scientist, Immunicon Corporation, Huntingdon Valley, Pennsylvania

Head of Analytical Methods Development

Supervisor of assay development group, which was responsible for development of assays for determining the efficacy of manufactured reagents for FDA 510K approved CellSearch Circulating Tumor Cell diagnostic test.

Scientist, Microparticle Group

Responsible for design and development of conjugation protocols for cancer cell marker antibodies to magnetic microparticles. Development of protein to nanoparticle conjugation processes.

Molecular Biology

Cloning and expression of a soluble form of EpCAM antigen in a baculovirus expression system for use in nanoparticles testing.

3/1998-9/1999 Quality Control Manager, Rockland Immunochemicals, Boyertown, Pennsylvania

Manager of quality control department and personnel, including product testing and assays. Supervised product release, including antibodies and other proteins from in house and third party manufacturers. Implemented procedures for quality control testing of new and existing products. Development of new products for sale. Perform custom services and technical service for customers.

3/1996-2/1998 Senior Scientist, Geo-Centers, Inc. Rockville, Maryland

Responsible for developing expression and large-scale purification processes for production of recombinant biotechnology products (antibodies against terrorist threat agents, nerve agent degrading enzymes) for the US Army.

8/1995-2/1996 Contract Research Scientist, Batelle Scientific, Inc. Columbus, Ohio

Responsible for developing a baculovirus expression system for production of recombinant antibody against botulinum toxin.

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8/1990-7/1995 Research Assistant, PhD Dissertation, Division of Biochemistry, University of Maryland, College Park, Maryland

Responsible for cloning, sequencing, and overexpression of the phosphonate degrading enzyme phosphonoacetaldehyde hydrolase.

7/1988-8/1990 Research Technician, Department of Biochemistry, University of North Carolina, Chapel Hill, North Carolina

Responsible for technical assistance in a university research laboratory.

9/1986-6/1988 Research Technician, Department of Neuroscience, Nathan Kline Institute, Orangeburg, New York

Responsible for technical assistance in a research laboratory, including protein purification, cell culture, SDS-PAGE, western blotting, small animal dissection, ultracentrifugation, ordering supplies.

Teaching Experience:

9/2007 to Present- Adjunct Faculty, Widener University, Chester, PA

Teach General Chemistry Labs I and II for Fall and Spring Semesters.

9/2001 to 2008- Adjunct Faculty, Cabrini College, Radnor, PA

Responsible for teaching General Chemistry Labs, 1st and 2nd semester; teach

Scientific Perspectives lecture and laboratory, a general science course for non

science majors that includes Chemistry, Physics, Astronomy, and Geology; taught

lab for Environmental Chemistry.

Publications

Baker, AS; Ciocci, MJ; Metcalf, WW; Kim, J; Babbitt, PC; Wanner, BL; Martin, BM; Dunaway-Mariano, D. Insights into the mechanism of catalysis by the P-C bond-cleaving enzyme phosphonoacetaldehyde hydrolase derived from gene sequence analysis and mutagenesis. Biochemistry 1998 Jun 30 (26); 9305-15

Ciocci, MJ; Sweeney, PJ; Olsen, GG; Emanuel, PA; Kracke, SK; Valdes, JJ. 5 Liter scale process for the production and purification of anti-botulinum toxin antibody. Scientific Conference on Chemical and Biological Defense Research. Nov. 1996, (p.47).

Sapirstein, VS; Nolan, CE; Stern, R; Ciocci, MJ; Masur, SK. Identification of the plasma membrane proteolipid protein as a constituent of brain coated vesicles and synaptic plasma membrane. J Neurochem 1988 Sep; (3); 925-33

Professional Affiliations

Member of the American Chemical Society

Honors and Awards

Selected co-chair for the “Advances in Affinity Methods” session for the American Chemical Society national meeting in March, 1999

References will be made available upon request.

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