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

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) analytics for large molecules alongside LC-MS/MS analytics for 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)

Summary

This position serves as functional management and provides scientific leadership with respect to Ligand Binding Assay (LBA) programs.  The manager will plan and conduct, as well as, advise team members on the development, validation and application of innovative LBA methods for PK/TK assessments, the detection and characterization of anti-drug antibodies and the quantitative determination of biomarkers.  In addition, this individual will troubleshoot scientific issues, provide input for scientific innovation, and aid business development by advising clients on technical matters.  This individual will provide input for scientific, operational, and business strategies for the LBA function and for the overall AIT Bioscience organization.

Position Requirements

  • Earned Ph.D. or M.S. with 5+ years of direct work experience in related LBA and service industries
  • Broad knowledge and expertise in the development and validation for bioanalysis of macromolecules and small molecule analytes utilizing various LBA designs and analytical platforms.  Protein MS experience preferred.
  • Experience troubleshooting bioanalytical problems.
  • Knowledge of the regulated development of biotherapeutics.
  • Knowledge and understanding of global regulatory guidance documents and relevant industry whitepapers.  Knowledge and understanding of FDA/EMA/OECD regulations and the ability to apply them daily.
  • Ability to clearly and concisely communicate bioanalytical information, including analytical results, in oral, written and electronic formats.  Due to the unique systems employed by the company, the successful candidate must have a high level of competency in computer systems, and be comfortable with the practice of operating in a paperless environment
  • The ability to implement or lead strategies and client projects with minimal supervision.
  • Possesses leadership skills and has the ability to work collaboratively in a team-oriented setting.
  • Possesses knowledge of the instrumentation and the skills required for performing user-level preventive maintenance, troubleshooting, and calibration.

Primary Duties and Responsibilities

  • Performs analysis and interpretation of data from analytical instrumentation.
  • Works closely with the AIT Bioscience BD organization to grow business and aid clients in refining project needs.
  • Advises scientific staff to determine appropriate strategies and experiments to assist in methods development and problem resolution for ligand binding assay methods.
  • Responsible for management of client projects and timelines
  • Manages internal resources and monitor metrics for team efficiency and business success.
  • Leader for quality processes with respect to LBA.  Reviews established standard operating procedures (SOPs) for consistency with current industry and regulatory guidance documents related to LBA.  Updates current SOPs and generates new SOPs as needed.
  • Leads staff and co-workers to meet applicable regulatory expectations and requirements for LBAs.
  • Maintains confidential information and complies with AITB policies.
  • Interacts professionally and constructively with external and internal colleagues at all levels.
  • Demonstrates independence and good leadership skills
  • Mentors staff professionally and scientifically to assist them in personal advancement and goal achievement.

 

Supervisory Responsibilities

Supervises 2 - 6 scientific staff, as assigned; provides guidance as needed to other laboratory and operations staff with respect to LBAs.

AIT Bioscience
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