Dan Aguiar

Experience

• 

  Arizona State University

  Aug 2007 - Jan 2008

  Research Assistant

  Assisted Professor Kevin McGraw in a semester long research project to assess the correlation between cortisol levels in avian blood and carotene intensity/concentration in birds' beaks.Induced a stress response every day in the birds to raise their stress hormone levels, and regularly removed a small amount of avian blood to determine cortisol levels.

• 

  City of Peoria

  Dec 2007 - Aug 2008

  Laboratory Technician

  Responsible for accurate drinking water sampling, testing, reporting, and chain of custody verification.Performed required quality control verification following GLP protocols and EPA guidelines including laboratory sterility checks, process verification and instrumentation validation.Competent in buffer preparation, UV testing, and bacterial count testing through managing the environmental lab.Improved processes for more efficient and consistent sample assessment.

• 

  VMC

  Jul 2010 - Sept 2010

  Hardware QC Analyst

  -Performed Hardware QC testing at the Redmond Campus to ensure QC standards were met or exceeded.

• 

  BioStorage Technologies, Inc.

  Sept 2010 - May 2015

  Biobank Curator and On-Site Coordinator for Sample Management for Amgen Inc.

  Biobank Curator Responsibilities• Enable Amgen to re-purpose its archived Biobank for biomarker development and non-protocol specified testing.• Work with principle investigators across all research departments to formulate sample sets based on research requirements, sample parameters, and subject consent.• Coordinate the rapid transfer of samples and data out of worldwide off-site storage to global testing facilities• Act as a liaison between Amgen and its multiple external storage providers.Sample Management On-Site Coordinator Responsibilities• Operate and maintain a GLP regulated sample management lab including receiving, storing, and tracking of biological samples for Amgen's global studies and commercial products.• Optimize the biological sample lifecycle to improve efficiency and accuracy through minimizing sample touches and other lean processes.• Supervisor for all biological sample management laboratory operations.• Sample management point of contact for internal and external audits.• Worked with Amgen management to resolve issues during the department migration to an external company.• Process samples into LIMS database using the corresponding study and sample demographic information. • Managed outbound shipping to appropriate domestic and international sites while following all requirements for biological substance category B (UN 3373) and IATA protocols.Accomplishments• Mapped every department process creating detailed reference workflows to be used for process improvement and alignment in addition to being used as standardized training documents.• Zero findings for audits conducted during my current role as On-Site Coordinator.• Defined scope, responsibilities and deliverables for the new position and presented these to Amgen upper management for approval.• Managed the transfer of 500,000 long term storage samples at ICON to Amgen’s preferred storage provider. Show less

• 

  Juno Therapeutics, Inc.

  May 2015 - Jul 2020

  • Quality Control Supervisor

    Sept 2017 - Jul 2020

  • Quality Control Specialist

    Sept 2016 - Sept 2017

  • Quality Control Sr. Associate

    May 2015 - Sept 2016
• 

  Bristol Myers Squibb

  Jul 2020 - now

  Current Responsibilities & Accomplishments • Developed and currently Manage a first-in-network QC System Support team of 27 with the following responsibilities:o QC Quality event oversight (Deviations, CAPAs, Change Controls, Laboratory Investigations) o Asset Lifecycle Management (From purchasing to validation to retirement) o LIMS System business ownership o Scheduling of testing and recurring activities in the laboratory using SmartQC automated scheduling application (and business ownership of SmartQC)o QC Sample Managemento Laboratory Support and resupplyo Equipment and Computer System Validationo Data Integrity• Hosted multiple regulatory inspection tours on behalf of QC including during the FDA PLI for commercial approval. • Responded to inspection information requests and presented follow-up data/responses to inspectors to mitigate potential findings. This includes inspections by FDA, CA, EMA, and JP health authorities.• Zero regulatory findings to date for areas under my management. • First site in BMS network to develop and deploy SmartQC to automate test scheduling to increase lab efficiency and throughput.• Developed and deployed electronic laboratory notebooks for all release methods to eliminate the need for paper during method execution in the lab. Show less Current Responsibilities & Accomplishments • Developed and currently Manage a first-in-network QC System Support team of 27 with the following responsibilities:o QC Quality event oversight (Deviations, CAPAs, Change Controls, Laboratory Investigations) o Asset Lifecycle Management (From purchasing to validation to retirement) o LIMS System business ownership o Scheduling of testing and recurring activities in the laboratory using SmartQC automated scheduling application (and business ownership of SmartQC)o QC Sample Managemento Laboratory Support and resupplyo Equipment and Computer System Validationo Data Integrity• Hosted multiple regulatory inspection tours on behalf of QC including during the FDA PLI for commercial approval. • Responded to inspection information requests and presented follow-up data/responses to inspectors to mitigate potential findings. This includes inspections by FDA, CA, EMA, and JP health authorities.• Zero regulatory findings to date for areas under my management. • First site in BMS network to develop and deploy SmartQC to automate test scheduling to increase lab efficiency and throughput.• Developed and deployed electronic laboratory notebooks for all release methods to eliminate the need for paper during method execution in the lab. Show less

  • Associate Director, Quality Control

    Sept 2022 - now

  • Senior Manager Quality Control

    Jul 2020 - Sept 2022