AIT Bioscience
  • - LBA
  • Indianapolis, IN, USA
  • Salary
  • 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 group management and provides scientific leadership with respect to Ligand Binding Assay (LBA) programs.  The director will oversee all LBA scientific activities, including advising team members on the development, validation and application of innovative LBA methods for PK/TK assessments, the detection and characterization of anti-drug antibodies (immunogenicity), and the quantitative determination of biomarkers.  This individual will troubleshoot scientific issues, provide input for scientific innovation, and aid business development by advising clients on technical matters.  This individual will also 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 10+ years of direct work experience in developing and validating LBA assays (PK/TK, ADA, NAB, biomarkers) in a regulated environment. CRO experience a plus.
  • Broad knowledge and expertise in the bioanalysis of biotherapeutics utilizing various LBA designs and analytical platforms.  Protein MS experience a plus.
  • Expertise troubleshooting LBA-related bioanalytical problems.
  • Strong leadership skills with the ability to direct a team of in-lab scientists to effectively deliver LBA methods and bioanalytical data to clients, while simultaneously working in a collaborative team-oriented setting.
  • 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.
  • 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
  • Ability to clearly and concisely communicate with employees and clients in oral, written and electronic formats. 

Primary Duties and Responsibilities

  • Advises LBA team to develop scientific strategies and to execute appropriate experiments to complete method development, method validation and problem resolution for LBA methods (PK/TK, ADA, NAB, biomarkers).
  • Responsible for LBA scientific processes and deliverables.
  • Responsible for management of client projects and timelines.
  • Manages internal resources and monitor metrics for team efficiency and business success.
  • Leads quality processes for LBA team, working in close collaboration with the Quality Assurance unit.  Reviews established standard operating procedures (SOPs) for consistency with current industry and regulatory guidance documents.  Updates current SOPs and generates new SOPs as needed for LBA offerings.
  • Works closely with the AIT Bioscience BD organization to grow business and aid clients in refining project needs.
  • 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.
  • Maintains confidential information and complies with AITB policies.

Supervisory Responsibilities

Supervises LBA PhD and non-PhD scientists who are responsible for the generation and execution of LBA methods.  Provides guidance, as needed, to other laboratory and operations staff with respect to LBA analyses.





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AIT Bioscience

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