Biologist

2 months ago

omaha, United States Insight Global Full time

Must Have:

  • Bachelor or masters in biology microbiology
  • 1-3 lab experience
  • Experience with one of the following: Invitro testing, immuno assays, ELISA testing
  • Ability to conduct scientific experiments, interpret results, and communicate with relevant team members and stakeholders
  • R&D, QC, interacting

Plusses:

  • Animal Health experience
  • USDA/FDA

Day-to-day

Insight Global is seeking a Reference Specialist for fortune 100 company in the pharmaceutical industry. This person will need to have a background in biology, microbiology, or virology. Working in the lab 3/4 of the day. Executing experiments and preparing write ups for documentation of testing. They will be working with cross functional groups in Quality, R&D, and Operations. Additional duties below

  • Assists in the maintenance of the reference management program for U.S. biologics sites
  • Maintains compliance according to USDA guidelines and requirements for reference standards and in vitro potency tests
  • Conducts in vitro stability testing of reference standards of pre- and post-licensure products
  • Prepares and tests small-scale vaccines to support formulation of new reference standards
  • Supports the formulation, dispense and testing of new reference standards as part of the reference qualification process
  • Making prototypes and testing them in ELISA
  • Dispensing into vials
  • Qualifying reference standards
  • Participates and collaborates in cross-functional teams with colleagues from R&D, Bio Technology Solutions-Analytics, Production, Quality Control, and Regulatory Affairs to support qualification of new reference standards
  • May assist in the preparation of protocols or reports for submission to USDA
  • May participate in critical reagent qualification studies
  • May provide technical support for approved Quality Control

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