Post Job Free

Resume

Sign in

Manager Product Development

Location:
New York, NY
Salary:
90,000
Posted:
February 25, 2016

Contact this candidate

Resume:

John Frenna

**** **** ******

Brooklyn, NY *****

Phone: 516-***-****

e-mail: acto7v@r.postjobfree.com

Profile:

A committed laboratory leader known for assay optimization and technical excellence. Possessing ten years of experience in scientific benchwork and department leadership. Seeking a position that provides challenging opportunities to manage scientific projects, demands integrity, and allows for personal development and career growth. Experience:

Scimedx Corporation (November 2012 – Present); Manager – Cell Biology, Product Manager – IFA

Production planning and facilitation for infectious and autoimmune IFA (Indirect Fluorescent Assay) slides and parasitic EIA kits

Manage Quality Control of all IVD components (controls, conjugates, diluents, wash buffers,) o Accomplishment: Successfully implemented QC program for Infectious IFA slides

Technical director for standardizing viral infections and maintaining the integrity and sterility of mammalian cell cultures (various human, primate, and rodent derived cell lines – adherent and suspension cultures)

Facilitate content marketing via literature for distribution at trade shows, use customer-centricity to target new distributors and under-served regions.

Assay development for cell-based toxicity and viability assays

Ensure safety and accuracy of product and gain regulatory agency approvals leading to CE marking, 510K FDA approvals. Knowledge of 21 CFR and ISO13485

Contribute to qualifying manufacturing processes- IQ/OQ/PQ, DOE o Accomplishment: Completed document transfer from company acquisition

Direct contact for all customer inquiries, complaints, technical service and market/new product development

Oversee all Biology department activity

o Experimental design development, SOP protocol development and implementation, customer correspondence, all fluorescent microscopy applications, and employee training o Purchasing, Manage spending and cost analysis

o Solidify the corporations place in the In-Vitro Diagnostics community with a comprehensive line of reliable IFA kits

Accomplishment: Successfully coordinated collaborations with various external BSL-3 research facilities to increase our product and diagnostic capabilities beyond BSL-2 classified infectious diseases

Pall Corporation (April 2012 – November 2012); Associate Scientist – Scientific and Laboratory Services

Project Manager for internal and external customer related inquiries – Organize testing for customer complaints, Data analysis and report output, Protocol design,

o Accomplishment: Assay optimization of PALL products for external customer collaboration – from screening of small molecule targets, dose response on tumor cell lines, cell based assays (ATP for toxicity & viability, and capsase for apoptosis, VEGF & EGFR for growth factor), protein expression screening via SDS-PAGE

/ Western Blot

Applications contact for Pall Corporation Rapid Microbiology GeneDisc system – Customer support for GeneDisc consumables and PCR analysis for BioPharm, Food and Beverage, and Environmental applications. Customer and internal training for enrichment, extraction, and PCR protocols.

Technical lead for increasing lab capabilities – Chromatography applications for protein purification and stability studies, Assay development for Confocal Microscopy techniques for Virus removal membranes, SEC, and ionic exchange chromatography beads

o Accomplishment: Successful collaboration with Albert Einstein College of Medicine – Creating multiplex image stacks from multiple confocal microscopy fluorophores.

Technical Contact for R&D Molecular Diagnostics – Optimizing protocols for customer products and/or applications for the following: Western Blots, Southern Transfers, DNA hybridizations, PCR analysis, Lateral Flow assays for plasma separation membranes and diagnostics for immunoassay development with antibody capture Pall Corporation (December 2006 – July 2010 / July 2010 – April 2012); Project Specialist/Senior Project Specialist – Biochemistry

Project Management for R&D Biomedical Group – Coordination and execution of ELISA assays (Coagulation markers [TATIII, F-1,2, D-Dimer, Factor V-XI] Cell activation [TCC], Platelet [PF4, B-Tg] and White Cell Markers

[Neutrophil Elastase]), Assay development for in house ELISA and protein quantifications

Project Leader of independent studies – Blood to filter interactions, Virus filtration and Ultrafiltration analysis o Accomplishment: Development of White Blood Cell tracking in filtration using fluorescence detection. o Accomplishment: Development of confocal microscopy capabilities

Miscellaneous responsibilities: Statistical analysis (ANOVA, T-Tests, ANOM); Purchasing contact for all proteins, DNA/RNA supplies, and antibody technology

Internal Auditing for ISO 14001 – Responsible for performing audits of Life Science, Biomedical, and Industrial business areas and maintained document control standards.

First Aid Responder (CPR / AED / First Aid / Blood Born Pathogen Certified) Pall Corporation (March 2005 - December 2006); Lab Analyst/Senior Lab Analyst – Microscopy Lab

Research analysis with filter media – Fluorescent and confocal microscopy for observing blood to filter interactions and cell tracking

Assisting in new product development

Membrane microstructure analysis, contaminant and particulate investigation, determining CWST (wettability) of membranes

SEM/EDS and AFM(Atomic Force Microscopy) for filter research on pore size and media topography Technical and Related Field Skills:

Cell Biology: Mammalian cell culture (suspension and adherent cell lines), Virology

Antibody Technology: ELISA, Production of Monoclonal Antibodies, Tissue Culture

Molecular Biology: Southern Blots, Western Transfers, Isolation of Plasmid DNA, PCR, Microarray

Biochemistry: GC/MS, HPLC, LC – work with GE AKTA Explorer

Microbiology: Bacterial transformation, Sterility checks and Viral titration

Biomedical: Perform blood filtrations for Leukoreduction and stem cell harvesting, Flow cytometry

Microscopy: Confocal and Fluorescent Microscopy, SEM/EDS, Atomic Force Microscopy

Computer and Software: Windows and MacOS, Microsoft Office (Word, Excel, PowerPoint, Project), Image J, Softmax Pro, Lotus Notes GraphPad Prism, Quality Analyst and Minitab

Miscellaneous: Maintenance of laboratory notebook, Constructing formal R&D technical reports, ISO9001, ISO14001, and ISO13485 compliance

Education:

St. John’s University – Jamaica, NY (2010)

Master of Science in Pharmaceutical Biotechnology

Rochester Institute of Technology - Rochester, NY (2004) Bachelor of Science in Biotechnology with a Minor in Music Publications:

Article: Hoory, E. Dubitsky, A. Frenna J. Surface Electrophoresis of DNA on Microporous Material. American Physical Society. March, 2006.

Poster: Dubitsky, A. Frenna, J. Streamlined Fluorescent Detection of Proteins after Western Transfer. Presented at the Conference for the Society of Biomolecular Sciences. Montreal, QC. April 2007

Poster: Bradbury, L. Frenna, J. Li, H. Streamlined Purification of Plasmid DNA from Prokaryotic Cultures Pall Corporation, Port Washington, NY, Woburn, MA and Ann Arbor, MI



Contact this candidate