Experience

Veloxity Labs, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director Of Quality Assurance

  • Jun 2022 - Present



BioAccurate Enterprises, Inc.

• Vancouver, Canada

• President / Consultant

  • Jan 2008 - Present

  Conducts GLP/GCP/CLIA-compliant Bioanalysis, Biomarker, Immunotherapeutics or Central Labs audits; Conducts GCP and GLP laboratory/facility qualifications; Conducts quality process, SOP, and facility and laboratory gap analyses, and respective laboratory and process improvement consulting; Manages and monitors bioanalytical and biomarker study outsourcing (clinical and preclinical) and provides project management support for GLP, GCP and animal health programs on behalf of the sponsor; Conducts mock FDA inspections, remediation and CAPA support and study pre-submission review; Advises on validation of biomarker and bioanalytical methods validation/qualification, and support the preparation of protocols, reports and SOPs; Consults on Large Molecule drug attrition processes in the GLP lab; Prepares biotechnical due diligence reports that provides technical insights, including biotechnology pipeline SWOTs and market risks. Show less



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Director of Laboratory Compliance

  • Jul 2019 - Jan 2021



Esoterix Labs (A LabCorp Subsiduary)

• Englewood, CO

• Director of Research and Development

  • Jan 2017 - Jul 2019



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director [Bioanalysis and Analytical Chemistry]

  • 2015 - Nov 2016

  Supports staff of 100 scientists associated with bioanalysis, immune monitoring assays, ADA, analytical chemistry, and sample management in support of Sponsor pre-clinical and clinical studies. Supports staff of 100 scientists associated with bioanalysis, immune monitoring assays, ADA, analytical chemistry, and sample management in support of Sponsor pre-clinical and clinical studies.



Lovelace Biomedical Research Institute

• United States
• Research Services
• 100 - 200 Employee

• Associate Director [Bioanalysis]

  • Jun 2014 - Nov 2015

  Manages preclinical and clinical bioanalysis, ICL (Immunology Core Lab), Virology and Microbiology. This position required direct communications with Federal and Commercial clients. Manages preclinical and clinical bioanalysis, ICL (Immunology Core Lab), Virology and Microbiology. This position required direct communications with Federal and Commercial clients.



Advion Interchim Scientific

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Research Scientist / Principle Investigator

  • 2003 - 2006

  Developed and validated LC/MS/MS methods for clinical and pre-clinical GLP studies and functioned as P.I. with direct interactions with client and FDA/client during audits. Developed and validated GLP-compliant drug-drug interaction (P450) assays and managed respective department. Presented at conferences topics relevant to services and technology (Triversa). Wrote relevant Protocols, Analytical Methods and Summaries, Final Reports, and SOPs for contractual analytical studies as a principle investigator. Developed and implemented business plan for new GLP drug-drug interaction services. Increased processes through introduction of HTS methods, new technologies and leadership. Developed research programs and collaborations to facilitate additional services including GLP-compliant LC-MS/MS P450 screening. Show less



Eli Lilly and Company - Canada

• Ontario, Canada

• Associate Senior Scientist - Bioanalytical

  • Feb 2003 - Feb 2004

  Development and validation of bioanalytical (LC-MS/MS) methods. Principle investigator on GLP bioanalytical studies. Member of Eli Lilly GLP/SOP team with role of harmonizing GLPs and internal SOPs Development and validation of bioanalytical (LC-MS/MS) methods. Principle investigator on GLP bioanalytical studies. Member of Eli Lilly GLP/SOP team with role of harmonizing GLPs and internal SOPs



Chemokine Therapeutics Corp.

• Vancouver, BC, Canada

• Director of Biology - Stem Cell Therapeutics and Cancer/MS Division

  • Oct 2000 - 2002

  Managed department in the development of high-throughput biological assays (immunoassay and cell-based) for screening of small molecule libraries and rationally-designed peptides for chemokine/receptro mimetics and antagonists. Managed all pre-clinical studies and University collaborations. Supported Medicinal Chemistry and SAR projects. Prepared and submitted patents. Managed department in the development of high-throughput biological assays (immunoassay and cell-based) for screening of small molecule libraries and rationally-designed peptides for chemokine/receptro mimetics and antagonists. Managed all pre-clinical studies and University collaborations. Supported Medicinal Chemistry and SAR projects. Prepared and submitted patents.



BioChem Pharma, Inc [Now Shire]

• Quebec, Canada

• Senior Research Associate

  • 1996 - 1999

  Developed biological methods for screening of rationally-designed drug candidates, and HTS. Mediated QSAR interpretations for development of screening assays. Developed HPLC methodologies for novel compound. Team leader for ADME and pre-clinical outsourcing. Developed biological methods for screening of rationally-designed drug candidates, and HTS. Mediated QSAR interpretations for development of screening assays. Developed HPLC methodologies for novel compound. Team leader for ADME and pre-clinical outsourcing.



Bristol-Myers Squibb

• Wallingford, CT

• Research Associate - Metabolism and Pharmacokinetics

  • 1988 - 1991

  HLPC method development and analysis for pre-clinical samples relevant to oncology program. 32-hrs/week and full-time summers. HLPC method development and analysis for pre-clinical samples relevant to oncology program. 32-hrs/week and full-time summers.