Experience

ProterixBio, Inc

• United States
• Biotechnology Research
• 1 - 100 Employee

• Independent Consultant

  • Mar 2019 - May 2019

  Performed Good Laboratory Practice (GLP)/21CFR Part 58 analysis of the Laboratory Operations aspect of the ProterixBio, Inc. business. Reviewed compliance with regulatory guidelines regarding clinical sample analysis, documentation, computer systems, training, safety, and operations. Provided an in-depth report of my findings regarding standard operating procedures, documents, forms and work instructions. I made critical recommendations on the course of action that would lead to compliance with… Show more Performed Good Laboratory Practice (GLP)/21CFR Part 58 analysis of the Laboratory Operations aspect of the ProterixBio, Inc. business. Reviewed compliance with regulatory guidelines regarding clinical sample analysis, documentation, computer systems, training, safety, and operations. Provided an in-depth report of my findings regarding standard operating procedures, documents, forms and work instructions. I made critical recommendations on the course of action that would lead to compliance with FDA regulations for clinical sample analysis. Show less Performed Good Laboratory Practice (GLP)/21CFR Part 58 analysis of the Laboratory Operations aspect of the ProterixBio, Inc. business. Reviewed compliance with regulatory guidelines regarding clinical sample analysis, documentation, computer systems, training, safety, and operations. Provided an in-depth report of my findings regarding standard operating procedures, documents, forms and work instructions. I made critical recommendations on the course of action that would lead to compliance with… Show more Performed Good Laboratory Practice (GLP)/21CFR Part 58 analysis of the Laboratory Operations aspect of the ProterixBio, Inc. business. Reviewed compliance with regulatory guidelines regarding clinical sample analysis, documentation, computer systems, training, safety, and operations. Provided an in-depth report of my findings regarding standard operating procedures, documents, forms and work instructions. I made critical recommendations on the course of action that would lead to compliance with FDA regulations for clinical sample analysis. Show less



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, Immunoanalytical Services

  • Jul 2016 - Nov 2018

  In my role as Associate Director I was responsible for managing an experienced team of scientists as well as research associates in a state of the art GLP immunoanalytical laboratory. I participated in and directed phamacokinetic and immunogenicity method development, method validation, and clinical sample analysis for three major pharmaceutical programs, as well as smaller projects for biotechnology companies. Technologies employed included ELISA and electroluminescence assays (Meso Scale… Show more In my role as Associate Director I was responsible for managing an experienced team of scientists as well as research associates in a state of the art GLP immunoanalytical laboratory. I participated in and directed phamacokinetic and immunogenicity method development, method validation, and clinical sample analysis for three major pharmaceutical programs, as well as smaller projects for biotechnology companies. Technologies employed included ELISA and electroluminescence assays (Meso Scale Discovery). Data and sample information were managed using Watson LIMS. I was responsible for client interactions, clinical trial management, budget and GLP infrastructure building for this business unit at Charles River Laboratories.

• Principal Scientist II, Immunoanalytical Services

  • Apr 2015 - Jul 2016

  In my role as Principal Investigator I was responsible for building an experienced team of scientists and a state of the art GLP immunoanalytical laboratory. I participated in and directed phamacokinetic and immunogenicity method development, method validation, and clinical sample analysis for three major pharmaceutical programs. Technologies employed included ELISA and electroluminescence assays (Meso Scale Discovery). Data and sample information were managed using Watson LIMS. I was… Show more In my role as Principal Investigator I was responsible for building an experienced team of scientists and a state of the art GLP immunoanalytical laboratory. I participated in and directed phamacokinetic and immunogenicity method development, method validation, and clinical sample analysis for three major pharmaceutical programs. Technologies employed included ELISA and electroluminescence assays (Meso Scale Discovery). Data and sample information were managed using Watson LIMS. I was responsible for client interactions, clinical trial management, budget and significant GLP infrastructure building for this business unit at Aglilux Laboratories.



ProterixBio, Inc

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director, Assay Development and Kit Manufacturing

  • Nov 2010 - Mar 2015

  I managed two teams at BioScale, the Acoustic Assay Development team and the Biologicals Manufacturing team. Assay development achievements include leading the development of BioScale's menu of Acoustic Assays for the ViBE protein analysis instrumentation platform. These comprise an assay panel for the measurement of physiologically important kinases and biomarkers, including intracellular and membrane bound proteins. These assays are being used for in vitro, xenograft, and tumor studies… Show more I managed two teams at BioScale, the Acoustic Assay Development team and the Biologicals Manufacturing team. Assay development achievements include leading the development of BioScale's menu of Acoustic Assays for the ViBE protein analysis instrumentation platform. These comprise an assay panel for the measurement of physiologically important kinases and biomarkers, including intracellular and membrane bound proteins. These assays are being used for in vitro, xenograft, and tumor studies, internally and with pharmaceutical and academic collaborators. Our work has been highlighted in collaborative poster presentations at the American Association for Cancer Research meetings for the past three years. I led and mentored 4 scientists utilizing classical assay development techniques and data analysis with BioScale’s Acoustic Magnetic Microparticle (AMMP) technology and ViBE instrumentation. We correlated BioScale technology with both Western blot and ELISA as part of the assay validation process. My team authored the literature and technical notes required for customer use of our products. I managed the manufacture BioScale's product line of cytokine and biomarker immunoassays and specialty assay development reagents. I oversaw the standard operating procedures and quality control methods for production and release testing of the product line as well as the distribution of our products. My team was responsible for the training, documentation and successful delivery of our biological products to our customers world wide. Show less I managed two teams at BioScale, the Acoustic Assay Development team and the Biologicals Manufacturing team. Assay development achievements include leading the development of BioScale's menu of Acoustic Assays for the ViBE protein analysis instrumentation platform. These comprise an assay panel for the measurement of physiologically important kinases and biomarkers, including intracellular and membrane bound proteins. These assays are being used for in vitro, xenograft, and tumor studies… Show more I managed two teams at BioScale, the Acoustic Assay Development team and the Biologicals Manufacturing team. Assay development achievements include leading the development of BioScale's menu of Acoustic Assays for the ViBE protein analysis instrumentation platform. These comprise an assay panel for the measurement of physiologically important kinases and biomarkers, including intracellular and membrane bound proteins. These assays are being used for in vitro, xenograft, and tumor studies, internally and with pharmaceutical and academic collaborators. Our work has been highlighted in collaborative poster presentations at the American Association for Cancer Research meetings for the past three years. I led and mentored 4 scientists utilizing classical assay development techniques and data analysis with BioScale’s Acoustic Magnetic Microparticle (AMMP) technology and ViBE instrumentation. We correlated BioScale technology with both Western blot and ELISA as part of the assay validation process. My team authored the literature and technical notes required for customer use of our products. I managed the manufacture BioScale's product line of cytokine and biomarker immunoassays and specialty assay development reagents. I oversaw the standard operating procedures and quality control methods for production and release testing of the product line as well as the distribution of our products. My team was responsible for the training, documentation and successful delivery of our biological products to our customers world wide. Show less



Blue Stream Laboratories

• Cambridge, MA

• Manager, Analytical Laboratory

  • Dec 2009 - Nov 2010

  Responsible for managing the day to day laboratory analysis performed in a contract research organization. Supervised a team of 6 scientists performing and reporting on results of routine analytical methods including HPLC, Mass Spectrometry, SDS-PAGE, capillary electrophoresis and western blot, under cGMP guidelines. Responsible for managing the day to day laboratory analysis performed in a contract research organization. Supervised a team of 6 scientists performing and reporting on results of routine analytical methods including HPLC, Mass Spectrometry, SDS-PAGE, capillary electrophoresis and western blot, under cGMP guidelines.



Advanced Instruments, LLC

• United States
• Biotechnology Research
• 100 - 200 Employee

• Laboratory Services Manager

  • Nov 2007 - Nov 2008

  Major responsibilities included two functions: Quality Control Manager and Product Development Project Leader. In the Quality Control role I was responsible for the timely testing and release of reagents used to calibrate and control Advanced Instruments’ analytical instrumentation product line for clinical and dairy laboratory applications. Our laboratory was also responsible for testing and validating updated versions of instrumentation and software as well as reagent manufacturing tasks… Show more Major responsibilities included two functions: Quality Control Manager and Product Development Project Leader. In the Quality Control role I was responsible for the timely testing and release of reagents used to calibrate and control Advanced Instruments’ analytical instrumentation product line for clinical and dairy laboratory applications. Our laboratory was also responsible for testing and validating updated versions of instrumentation and software as well as reagent manufacturing tasks to support the instrumentation and applications. I supervised a team of 4 technical specialists in this role. In the Product Development role I was responsible for the development of a novel bacterial detection product for various biological matrices. In this role I worked closely with engineers as well as outside collaborators. Most of my time on this project was spent in the laboratory as an individual contributor. In this role I supervised one engineer and one microbiologist. Show less Major responsibilities included two functions: Quality Control Manager and Product Development Project Leader. In the Quality Control role I was responsible for the timely testing and release of reagents used to calibrate and control Advanced Instruments’ analytical instrumentation product line for clinical and dairy laboratory applications. Our laboratory was also responsible for testing and validating updated versions of instrumentation and software as well as reagent manufacturing tasks… Show more Major responsibilities included two functions: Quality Control Manager and Product Development Project Leader. In the Quality Control role I was responsible for the timely testing and release of reagents used to calibrate and control Advanced Instruments’ analytical instrumentation product line for clinical and dairy laboratory applications. Our laboratory was also responsible for testing and validating updated versions of instrumentation and software as well as reagent manufacturing tasks to support the instrumentation and applications. I supervised a team of 4 technical specialists in this role. In the Product Development role I was responsible for the development of a novel bacterial detection product for various biological matrices. In this role I worked closely with engineers as well as outside collaborators. Most of my time on this project was spent in the laboratory as an individual contributor. In this role I supervised one engineer and one microbiologist. Show less



Immunetics, Inc.

• Boston, MA

• Senior Scientist

  • Jan 2003 - Nov 2007

  Major contributor to the development of a rapid peptidoglycan-based assay for the detection of bacterial contamination in platelet units. Directed a team of scientists in optimization, verification and validation of the assay in a cGMP environment. Product performance data were presented yearly at the American Association of Blood Banks annual meetings. Part of the team of inventors that contributed to the patents for Immunetics' BacTX platelet bacterial detection product, which is now FDA… Show more Major contributor to the development of a rapid peptidoglycan-based assay for the detection of bacterial contamination in platelet units. Directed a team of scientists in optimization, verification and validation of the assay in a cGMP environment. Product performance data were presented yearly at the American Association of Blood Banks annual meetings. Part of the team of inventors that contributed to the patents for Immunetics' BacTX platelet bacterial detection product, which is now FDA approved for screening random donor leukoreduced platelet units prior to transfusion. Accomplishments also included the successful management of a year-long clinical trial for Immunetics’ Lyme ELISA which resulted in an FDA 510(k) submission. Responsibilities also included technical leadership for the improvement/redevelopment of Immunetics’ HIV western blot product. Responsibilities further included a major support role for many other areas in the company. Participated in technical support for all of Immunetics’ products. Involved in the creation of quality control procedures for many of Immunetics’ products. Responsible for safety, regulatory compliance and documentation (GMP, CLIA). Show less Major contributor to the development of a rapid peptidoglycan-based assay for the detection of bacterial contamination in platelet units. Directed a team of scientists in optimization, verification and validation of the assay in a cGMP environment. Product performance data were presented yearly at the American Association of Blood Banks annual meetings. Part of the team of inventors that contributed to the patents for Immunetics' BacTX platelet bacterial detection product, which is now FDA… Show more Major contributor to the development of a rapid peptidoglycan-based assay for the detection of bacterial contamination in platelet units. Directed a team of scientists in optimization, verification and validation of the assay in a cGMP environment. Product performance data were presented yearly at the American Association of Blood Banks annual meetings. Part of the team of inventors that contributed to the patents for Immunetics' BacTX platelet bacterial detection product, which is now FDA approved for screening random donor leukoreduced platelet units prior to transfusion. Accomplishments also included the successful management of a year-long clinical trial for Immunetics’ Lyme ELISA which resulted in an FDA 510(k) submission. Responsibilities also included technical leadership for the improvement/redevelopment of Immunetics’ HIV western blot product. Responsibilities further included a major support role for many other areas in the company. Participated in technical support for all of Immunetics’ products. Involved in the creation of quality control procedures for many of Immunetics’ products. Responsible for safety, regulatory compliance and documentation (GMP, CLIA). Show less



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Manager of Protein Chemistry

  • Mar 2001 - Jan 2003

  Responsible for the management of scientists in the design, development and validation of immunologically based assays (RIA, ELISA and Western blot) in a fully regulated cGMP (21 CFR) contract research organization. Responsible for client contact on multiple projects as well as interdepartmental coordination of workflow. Responsible for writing standard operating procedures, test methods, validation reports, and project development reports and final summary reports upon completion of… Show more Responsible for the management of scientists in the design, development and validation of immunologically based assays (RIA, ELISA and Western blot) in a fully regulated cGMP (21 CFR) contract research organization. Responsible for client contact on multiple projects as well as interdepartmental coordination of workflow. Responsible for writing standard operating procedures, test methods, validation reports, and project development reports and final summary reports upon completion of projects. Show less Responsible for the management of scientists in the design, development and validation of immunologically based assays (RIA, ELISA and Western blot) in a fully regulated cGMP (21 CFR) contract research organization. Responsible for client contact on multiple projects as well as interdepartmental coordination of workflow. Responsible for writing standard operating procedures, test methods, validation reports, and project development reports and final summary reports upon completion of… Show more Responsible for the management of scientists in the design, development and validation of immunologically based assays (RIA, ELISA and Western blot) in a fully regulated cGMP (21 CFR) contract research organization. Responsible for client contact on multiple projects as well as interdepartmental coordination of workflow. Responsible for writing standard operating procedures, test methods, validation reports, and project development reports and final summary reports upon completion of projects. Show less



Pierce-Endogen

• Woburn, MA

• Manager, Immunassay Development

  • Apr 1993 - Mar 2001

  Pierce-Endogen, Inc. Woburn, MA Director, Immunoassay Development Apr. 1993 – Mar. 2001 Accountable for the complete design, development and validation of ELISA based assays in an ISO9001/ISO9002 environment for novel cytokines, growth factors, and other immunologically important proteins. Directed a team of scientists, ranging from 3-10 direct reports, in antibody production, characterization and purification, experimental planning and factorial design, data… Show more Pierce-Endogen, Inc. Woburn, MA Director, Immunoassay Development Apr. 1993 – Mar. 2001 Accountable for the complete design, development and validation of ELISA based assays in an ISO9001/ISO9002 environment for novel cytokines, growth factors, and other immunologically important proteins. Directed a team of scientists, ranging from 3-10 direct reports, in antibody production, characterization and purification, experimental planning and factorial design, data analysis, and complete ELISA development as well as various projects in all stages of the development process. Provided direction and instruction on lab techniques, overall testing, data reduction and presentation of validation reports for products under development. Contributed to the technical writing that was included in the product data sheets, technical bulletins and Endogen’s product catalogues. Communicated Endogen’s scientific accomplishments to the company, the board of directors, and the scientific community worldwide. Successfully brought to the research market more than 50 high quality cytokine ELISAs that included multiple platforms for colorimetric, fluorescent and chemiluminescent detection systems. Our laboratory presented over fifty posters describing our cytokine assay development at prestigious scientific meetings worldwide. Show less Pierce-Endogen, Inc. Woburn, MA Director, Immunoassay Development Apr. 1993 – Mar. 2001 Accountable for the complete design, development and validation of ELISA based assays in an ISO9001/ISO9002 environment for novel cytokines, growth factors, and other immunologically important proteins. Directed a team of scientists, ranging from 3-10 direct reports, in antibody production, characterization and purification, experimental planning and factorial design, data… Show more Pierce-Endogen, Inc. Woburn, MA Director, Immunoassay Development Apr. 1993 – Mar. 2001 Accountable for the complete design, development and validation of ELISA based assays in an ISO9001/ISO9002 environment for novel cytokines, growth factors, and other immunologically important proteins. Directed a team of scientists, ranging from 3-10 direct reports, in antibody production, characterization and purification, experimental planning and factorial design, data analysis, and complete ELISA development as well as various projects in all stages of the development process. Provided direction and instruction on lab techniques, overall testing, data reduction and presentation of validation reports for products under development. Contributed to the technical writing that was included in the product data sheets, technical bulletins and Endogen’s product catalogues. Communicated Endogen’s scientific accomplishments to the company, the board of directors, and the scientific community worldwide. Successfully brought to the research market more than 50 high quality cytokine ELISAs that included multiple platforms for colorimetric, fluorescent and chemiluminescent detection systems. Our laboratory presented over fifty posters describing our cytokine assay development at prestigious scientific meetings worldwide. Show less



Matritech, Inc

• Cambridge, MA

• Manager, Monoclonal Antibody Laboratory

  • 1989 - 1993

  Part of the team of scientists that discovered that Nuclear Matrix Proteins (NMP) circulate in the body fluids of cancer patients, and are also detectable in the growth medium of cancer cells in culture. This work contributed significantly to the company's intellectual property with many issued patents and applications pending, with the ultimate result of an FDA approved product for the detection of NMPs in the urine of bladder cancer patients; NMP22 BladderCheck. Significant contributor to… Show more Part of the team of scientists that discovered that Nuclear Matrix Proteins (NMP) circulate in the body fluids of cancer patients, and are also detectable in the growth medium of cancer cells in culture. This work contributed significantly to the company's intellectual property with many issued patents and applications pending, with the ultimate result of an FDA approved product for the detection of NMPs in the urine of bladder cancer patients; NMP22 BladderCheck. Significant contributor to two peer-reviewed journal articles and one book chapter on nuclear matrix proteins and their role in programmed cell death. Show less Part of the team of scientists that discovered that Nuclear Matrix Proteins (NMP) circulate in the body fluids of cancer patients, and are also detectable in the growth medium of cancer cells in culture. This work contributed significantly to the company's intellectual property with many issued patents and applications pending, with the ultimate result of an FDA approved product for the detection of NMPs in the urine of bladder cancer patients; NMP22 BladderCheck. Significant contributor to… Show more Part of the team of scientists that discovered that Nuclear Matrix Proteins (NMP) circulate in the body fluids of cancer patients, and are also detectable in the growth medium of cancer cells in culture. This work contributed significantly to the company's intellectual property with many issued patents and applications pending, with the ultimate result of an FDA approved product for the detection of NMPs in the urine of bladder cancer patients; NMP22 BladderCheck. Significant contributor to two peer-reviewed journal articles and one book chapter on nuclear matrix proteins and their role in programmed cell death. Show less