Biologist
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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