Experience

Forza Pharma Consulting, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• Principal

  • Mar 2019 - Present

  Quality System creation and implementation: - Periodic Review of Equipment Qualification - Equipment Risk Assessment - Deviation investigations Computer System Validation: - Veeva - ValGenesis Facilities enterprise management: - Blue Mountain Quality System creation and implementation: - Periodic Review of Equipment Qualification - Equipment Risk Assessment - Deviation investigations Computer System Validation: - Veeva - ValGenesis Facilities enterprise management: - Blue Mountain



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Investigator

  • Feb 2016 - Dec 2019

  Engineering & Technology investigator for minor and major (GMP impacting) deviations: - Drug product manufacturing - Filling (vial/syringe) - Packaging - Shipping validation - QC methods Engineering & Technology investigator for minor and major (GMP impacting) deviations: - Drug product manufacturing - Filling (vial/syringe) - Packaging - Shipping validation - QC methods



Delta Project Management

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Scientist - Validation

  • Nov 2012 - Dec 2019

  Process Validation Cleaning Validation Equipment Qualification 21CFR part11 compliant software qualification Project Management Deviation Investigation and CAPA Management Program author for site-wide equipment equivalence technical assessments Process Validation Cleaning Validation Equipment Qualification 21CFR part11 compliant software qualification Project Management Deviation Investigation and CAPA Management Program author for site-wide equipment equivalence technical assessments



Adaptive Biotechnologies Corp.

• United States
• Biotechnology
• 500 - 600 Employee

• Validation Scientist II

  • Jan 2018 - Jun 2018

  Report authoring/review of validation reports for next generation PCR-based in-vitro diagnostics. Limit of Detection, Limit of Quantitation, Accuracy, and Linearity assay analysis Sample Stability analysis Report authoring/review of validation reports for next generation PCR-based in-vitro diagnostics. Limit of Detection, Limit of Quantitation, Accuracy, and Linearity assay analysis Sample Stability analysis



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Validation contractor

  • Mar 2015 - Jan 2016

  Dry powder formulation equipment qualification: Blenders GEA Niro PMA Granulator Glatt granulators Gerteis Compactor Korsch tablet press Quadro Comil Tablet coating and dedusting equipment Dry powder formulation equipment qualification: Blenders GEA Niro PMA Granulator Glatt granulators Gerteis Compactor Korsch tablet press Quadro Comil Tablet coating and dedusting equipment

• Validation SME

  • Nov 2012 - Dec 2015

  Complete validation life cycle document authoring: - URS - Risk assessment - 21CFR part 11 compliance - IOQ execution - Trace Matrix - Summary report Equipment Qualification Cleaning Validation Process Performance Qualification FMEA and control strategy support Complete validation life cycle document authoring: - URS - Risk assessment - 21CFR part 11 compliance - IOQ execution - Trace Matrix - Summary report Equipment Qualification Cleaning Validation Process Performance Qualification FMEA and control strategy support



Catalyst Biosciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Scientist

  • 2009 - Sep 2012

  Protein Science Flask and fermentor protein expression, centrifuge harvesting CHO wave reactor assembly, seeding, and supernatant filtration Hollow fiber (TFF) concentrations Low-endotoxin gram scale enzyme purifications for preclinical studies Fluorescent enzyme and HPLC assays Protein Science Flask and fermentor protein expression, centrifuge harvesting CHO wave reactor assembly, seeding, and supernatant filtration Hollow fiber (TFF) concentrations Low-endotoxin gram scale enzyme purifications for preclinical studies Fluorescent enzyme and HPLC assays



diaDexus

• Biotechnology Research
• 1 - 100 Employee

• Sr. Research Associate, Associate Scientist

  • May 2001 - Oct 2009

  In Vitro diagnostic validation protocol authoring and execution: Olympus AU-400 and AU640 Chemistry Analyzer Roche Hitachi 912 Chemistry Analyzer Protein purification and characterization Assay development cGMP diagnostic manufacturing team lead Customer complaint support Hybridoma development and characterization Surface Plasmon Resonance for offrate and affinity ranking Biomek robotics High Throughput Screening In Vitro diagnostic validation protocol authoring and execution: Olympus AU-400 and AU640 Chemistry Analyzer Roche Hitachi 912 Chemistry Analyzer Protein purification and characterization Assay development cGMP diagnostic manufacturing team lead Customer complaint support Hybridoma development and characterization Surface Plasmon Resonance for offrate and affinity ranking Biomek robotics High Throughput Screening



Corixa Corporation

• United States
• Biotechnology
• 1 - 100 Employee

• RAII

  • 2000 - 2001

  Purified and characterized recombinant Major Histocompatibility Complex (MHC) fusion antigen proteins and antibodies for preclinical study of anergizing autoimmune T-cell populations (PAGE, IEF, 2D, and blots). Purified and characterized recombinant Major Histocompatibility Complex (MHC) fusion antigen proteins and antibodies for preclinical study of anergizing autoimmune T-cell populations (PAGE, IEF, 2D, and blots).



On Assignment Lab Support

• United States
• Human Resources Services

• RA

  • 2000 - 2000

  Protein support at Corixa. Protein support at Corixa.



KVSC radio

• Music

• Announcer

  • 1990 - 1992

  Radio announcer/DJ, production and general studio assistance. Radio announcer/DJ, production and general studio assistance.



KEYL Radio

• Automotive
• 1 - 100 Employee

• Announcer

  • 1989 - 1990

  Radio Announcer. Radio Announcer.