AIT Bioscience
  • - Laboratory
  • Indianapolis, IN, USA
  • Salary
  • Full Time

AIT Bioscience is growing! AIT Bioscience, LLC, headquartered in Indianapolis, Indiana, is an integrated contract research laboratory (CRO) that provides Bioanalytical services utilizing real-time quality control processes in Ligand Binding Assay (LBA) and LC-MS/MS analytics for large and small molecules in pre-clinical and phase I – III clinical trials. The integration of these services, supported by a state-of-the-art, smart, electronic laboratory environment, allows AIT Bioscience to devise the best solution for its clients, across each of its bioanalytical service areas. AIT Bioscience delivers robust analytical methods, highly-skilled and experienced client consultation, efficient sample logistics and rapid sample analysis from pre-IND through investigational new drug (IND), new drug application (NDA), abbreviated new drug application (ANDA) and Biologics License Application (BLA).


Position Summary

The Laboratory Scientist performs and manages tasks that result in accurate and timely method development, validation and sample analysis of chemical and biological entities in biological matrix in a regulated environment utilizing various analytical technologies in a ligand binding assay laboratory. Displays versatility and accuracy in performing laboratory duties.


Position Requirements
• Earned B.S. in a life science from an accredited institution; 1 – 5 years laboratory experience preferred.
• Skills required to independently perform bioanalytical method development, validation and/or product sample analysis utilizing various analytical technologies and/or assay formats, including ELISA and MSD assays. Prior experience with biomarkers, ADA and/or NAB a plus.
• Ability to learn, or experience in, GLP/OECD regulations and the ability to apply them daily
• The ability to clearly and concisely convey analytical results in oral, written, and electronic formats.
• The ability to follow clear oral and written instruction and confirm instructions are followed, including adherence to all standard operating procedures.
• Skills required for labeling, handling, processing and storage of samples.
• Working knowledge of reagent stability and storage; for performing instrument preventative maintenance, troubleshooting and calibration; and awareness of the factors that influence test results.
• Skills necessary for managing and coordinating multiple projects simultaneously.
• Strong communication skills, both oral and written.


Primary Duties

• Performs analysis and interpretation of data from analytical instrumentation.
• Communicates conclusions from analytical results.
• Prepares reagents, quality control, and calibration samples.
• Operates, calibrates, and maintains laboratory equipment and analytical instruments.
• May design method development and validation experiments for execution, as assigned.
• Adheres to established standard operating procedures consistent with current industry and regulatory guidance.
• Maintains working knowledge of GLP, and OECD regulations, as applicable, with the ability to apply this knowledge daily. Knowledge is updated through ongoing training and understanding gained from current industry whitepapers and symposia related to regulated bioanalysis
• May provide project direction to other laboratory staff


Supervisory Responsibilities

No direct supervisory responsibilities

AIT Bioscience
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