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