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Experienced Senior Scientist

Location:
Lavallette, NJ
Posted:
August 06, 2012

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Resume:

DANIEL R. NAVARRO

**** ******** ******, *** ~ Bronx, New York 10453

Mobile: 845-***-****

w83hom@r.postjobfree.com http://www.linkedin.com/in/danielnavarro

QUALIFICATIONS

Established professional Bio-Chemist with significant experience in scientific research and Immunodiagnostic assay development. Experience in management of both projects and direct reports. Proficient with both Acridinium Ester and ALP flash technologies and Design for Six Sigma tools. Interested in management opportunities for both assay development and manufacturing troubleshooting. Certified Six Sigma Green Belt.

EDUCATION

Health Professionals School of HUNTER COLLEGE, City University of New York, New York

Master of Public Health, Environmental and Occupational Health Sciences (EOHS), and Community Health Education (COMHE) with a specialization in Infectious Disease 2004

LEHMAN COLLEGE, City University of New York, Bronx, New York

Bachelor of Science/Masters in Chemistry with a specialization in Biochemistry, 1998

RELEVANT EXPERIENCE

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Senior Biochemist, IMMULITE (February 2010 – January 2012)

• Collaborated with Siemens Los Angeles Quality Control Department for the successful transfer of all immunodiagnostic platforms to New York

• Directly collaborated with in-house Quality Control Department to Streamline Los Angeles’ specific SOP’s to Tarrytown Work Instructions, validated all immunodiagnostics platforms and submitted final report

• Developed the Intact Para-Thyroid Hormone Immunoassay for the IMMULITE Platforms following GMP, GLP and SOP’s

• Using DOE’s, designed, performed and analyzed all data collected. This includes functional sensitivity, method correlation, stability, manufacturing robustness, interferences among other parameters.

• Manufactured bulk assay Calibrators, Master Curve Material, Adjustors, Controls, and Medical Decision Pools, following GMP and GLP methods.

• Co-wrote and presented final report to review board for clearance of scale-up assay manufacturing which included feasibility, annual stability reports and validation report

• Collaborated with the Regulatory Affairs and Labeling department at Siemens Healthcare Diagnostics for the proper submission of all necessary documents to the FDA and for Japanese registration. This included writing the IVDD, Pre-IDE, 510(k), MSDS, FFU, and assay disclaimers.

• Worked closely with the Labeling and Design departments to finalize all immunoassay packaging components. This incorporated writing a test kit packaging Grid, safety-related disclaimers, Quality Control insert (QC), design packaging layout and in some instances changes to existing packaging kits. Final approval signatures were attained in a board meeting in which I was the R&D representative.

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Critical Project for IMMULITE Analyzers: Validation of Scale-Up V-Mixer

Tarrytown, NY. June 2011- October 2011

Siemens Healthcare Diagnostics

In June 2011 I took over the responsibility of the V-Mixer validation. The V-Mixer is the only Scale-Up machine required for the manufacturing of all IMMULITE beads. Having a Validated V-Mixer was mission critical to the sustainment of the R&D department with assays quickly approaching the scale-up phase. Through carefully designed experiments past validation failures were determined. After implementing changes the validation protocol was initiated and successfully completed in October 2011.

DANIEL R. NAVARRO

PAGE TWO

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Senior Biochemist, ADVIA CENTAUR (August 2007 – December 2010)

• Principle scientist managing a team of scientist to develop the ADVIA Centaur and Centaur-CP Procalcitonin (PCT) Immunoassay

• Analyzed antibody molar excess and fragments such as Fab, Fab2 and whole IgG to drive assay sensitivity and immunoreactivity

• Implemented the DFSS tools to successfully design and optimize a robust PCT assay

• Completed all necessary studies such as reagent stability, sample handling, environmental studies, endogenous/chemical interference, release bulk testing, robustness, method comparison among other parameters

• Manufactured bulk assay Controls, Calibrators, Medical Decision Pools and Quality Control Panel following GMP and GLP procedures

• Successfully met all assay milestones ahead of target date; Wrote and presented final reports to European

and U.S. divisions. These included feasibility reports, Stability, and product development reports.

• Wrote all documents required to finalize immunoassay launch which included the following: IVDD, Pre-IDE, package Labeling, 510(k), MSDS, FFU, Disclaimers, Test Kit Packaging Grid, CMC changes to existing packaging kits.

• Collaborate with the Regulatory Affairs and Labeling department at Siemens Healthcare Diagnostics for the proper submission of all necessary documents to the FDA and for Japanese registration.

• Wrote IVDD, Pre-IDE, 510(k), MSDS, FFU and assay disclaimers.

• Worked closely with the Labeling and Design departments to finalize all immunoassay packaging components including test kit packaging Gird; safety-related disclaimers,

• Prepared Quality Control insert (QC), design packaging layout and in some instances changes to existing packaging kits.

• R&D representative in core team meetings, element team meetings and PSB meetings. Peer review board member for other assays

• Laboratory Safety Officer

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Critical Projects: Pre-Clinical trial for Procalcitonin

Chicago, IL. April 2009 – April 2009

Swedish Covenant Hospital

In 2008 I proposed a theory that an intermediate molecule was present in the progressive digestion of Procalcitonin that would be critical to the method comparison to the predicate assay. I developed the PCT Immunoassay using a secondary antibody identifying this intermediate fragment. The purpose of the Pre-clinical trial was to execute a method comparison study against the Vidas Kryptor assay to prove my theory. This was a critical step in the development cycle of the PCT assay. Over 200 fresh disease samples were analyzed on both platforms. The data proved that my theory was correct and the PCT immunoassay was cleared for scale-up manufacturing.

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Key Contributions to the eTSH3 immunoassay:

Tarrytown, NY. January 2007 – June 2007

In 2007 the development of the ADVIA Centaur eTSH3 assay had to be delayed. It was observed that as the eTSH3 reagents aged the baseline signal increased. This phenomenon affected the sensitivity of the assay causing many failures at the low end. I devised a comprehensive evaluation of the assay architecture to decipher the cause of the increasing low end signal and concluded the cause to be the binary reagent. Further studies confirm my findings and corrective actions allowed the company to move forward with the manufacturing of the eTSH3 assay.

DANIEL R. NAVARRO

PAGE THREE

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Design For Six Sigma (DFSS), Green Belt Training and Minitab Analysis (2007)

Instructor, Craig Peugnet Master Black Belt

• Completed a 4 week course of intense training learning Design For Six Sigma Black Belt, Minitab Analysis, and Quality Companion

• Employed and successfully used the DFSS tools for the development of the ADVIA Centaur PCT assay and the reformulation and enhancement of the Third Generation TSH assay and The IMMULITE Intact-Para-Thyroid Hormone assay

SIEMENS HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

DFSS Project: The enhancement of the Para-magnetic Particles using DFSS tool

Walpole, MA. April 2007 – June 2007

Manufacturing

In 2007 I was selected to a team of scientist to optimize the coupling of antibody to para-magnetic particles (PMP) under manufacturing conditions. The purpose of this project was to potentially reduce the amount of antibody that was coupled to the PMP without sacrificing assay performance characteristics. After completion of the study data was collected and final analysis demonstrated more robust assays with increase performance characteristics. This has allowed the company to cut cost on all assays that use the PMP’s.

BAYER HEALTHCARE DIAGNOSTICS

DIVISION OF RESEARCH AND DEVELOPMENT

Senior Research Associate Scientist, ADVIA CENTAUR (May 2006 – August 2007)

• Assisted in the reformulation of the fPSA Immunoassay for the ADVIA Centaur platforms

• Using the DFSS tools I Co-developed a eTSH3 immunoassay that had twice the sensitivity, used half the sample volume, was twice as fast to first result and significantly reduce the cost of critical raw materials by 30%

• Co-wrote the final report, presented to peer review board and the ADVIA Centaur eTSH3 assay launched worldwide in 2009

NEW YORK PRESBYTERIAN HOSPITAL

WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY, New York, New York

Senior Research Scientist, Department of Urological Oncology (February 1998 - May 2006)

• Over 8 years of extensive experience working with diverse suspension and adherent cell lines. These included CHO, LnCap, DU145, TSU, WT5 among many other cell lines

• Created stable cell lines expressing desire mutated protein of interest using transfection and radio label techniques

• Utilized molecular, immunological, radiological and biochemical techniques to study the progression and path of prostate cancer and renal cell carcinoma

• Designed and executed animal studies involving surgical procedures, expanding colonies, cross breeding, genotyping and radio labeling of proteins and chemo conjugated antibodies.

• Responsible for the development and implementation of active in-vivo protocols and Co-investigator of in-vivo protocols designed for the study of xenograph mouse models of prostate cancer and renal cell carcinoma

DANIEL R. NAVARRO

PAGE FOUR

• Collaborated with the department of pharmacology in analyzing patients pharmacokinetics of Retinoid

metabolism pre and post treatment using HPLC techniques

• Designed, developed and carried out study to elucidate functional properties and signaling pathways of JNEP through the use of molecular, FACS, immunological, radiological and biochemical techniques.

• Functional properties of JNEP were studied through the use of in-house developed antibodies and siRNA targeting JNEP in xenograph mouse models.

• siRNA transfection and efficiency confirmed through the use of Western Blot, ELISA and FACS.

• Performed immunoassays and worked extensively with cell and molecular biology techniques, including complement cytotoxicity, antibody dependent cytotoxicity, apoptosis, radioimmunoassay, ELISA, FACS, cell migration, immunofluorescence and immunohistochemistry.

• Contributed to research/development of innovative anti-bodies targeting prostate and renal cell carcinoma.

• Lead scientist in the collaboration of clinical trials with Nuclear Medicine preparing radio label cell lysate

• Safety officer for the laboratory and responsible for the proper use of radioisotope and contamination analysis



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