Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Associate Manager Compliance

  • Jan 2021 - Present

  Working on investigations, change controls and change notifications from contract manufacturing organizations handling our drug product while overseeing a compliance team.

• Senior Compliance Specialist

  • Sep 2019 - Dec 2020

  Rensselaer, NY Working on investigations and change notifications from contract manufacturing organizations handling our drug product.

• Process Science Associate III

  • Jul 2017 - Sep 2019

  Rensselear, NY Create, update and implement In-Process Controls through development reports, update associated manufacturing batch records, perform statistical analysis of in process data to revise current processing ranges, manage quality instances for the group.

• Supervisor Biotech Production

  • Aug 2015 - Jul 2017

  Supervisor role includes but is not limited to managing time cards, managing monthly performance reviews with direct reports and sub-direct reports, reviewing GMP write ups and forms, managing preventative maintenance schedule on equipment as well as validation activities, managing two processing areas overnight with minimal overhead management available and any deviations that occur. There is still an expected amount of time spent on the process floor to ensure continuity of purification.

• Biotech Production Specialist III

  • Jan 2014 - Aug 2015

  This job is focused around the clean room activities. Purifying protein by chromatography (size exclusion, anion, cation and hydrophobic interaction) as well as concentration/diafiltration. Process area support activities including deviation management, SOP edits, record keeping and quality assurance.

• Biotech Production Specialist II

  • Aug 2011 - Jan 2014

  Preparing buffer solutions for use over columns. Running protein purification via chromatography



Pace® Analytical Services

• United States
• Environmental Services
• 700 & Above Employee

• GC Analyst

  • Jun 2011 - Aug 2011

  Ran Hudson River samples through gas chromatography and analyzed chromatograms for PCB patterns and idenified which PCB was present in what concentration