AIT Bioscience
  • - LBA
  • Indianapolis, IN, USA
  • Full Time

Method Development Principal Investigator (PI), Ligand Binding Assays

We are currently seeking an experienced laboratory Scientist Method Development Principal Investigator (PI) with a minimum of 4 years of experience supporting GLP bioanalysis method development and validation in the ligand binding space. This role will interact and integrate with our validation and production teams in our state-of-the-art bioanalytical laboratory, and as Principal Investigator (PI) will verify the scientific integrity of the data and confirm that procedures are conducted in alignment with the Sponsor specifications and timelines. 

AIT Bioscience (AITB), a Nexelis Company, is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries.  LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioanalytical support for the development of new medicines, ranging from early-Discovery to Pre-Clinical support through to Clinical and Commercialization services.

AITB is the first and only CRO to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system.  With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it.  Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.

Fully qualified candidates may expect competitive compensation, commensurate with experience.  AITB offers a generous benefits package including medical, dental, vision, life, and disability insurance, 401(k) retirement plan, and the opportunity to work with a talented, dedicated and energetic workforce.

 

PURPOSE

The MD Senior Scientist/PI, Ligand Binding Assays will provide scientific and technical support for bioanalytical science deliverables (data and methods) and play a pivotal role in supporting AITB sponsored ligand binding and gene therapy projects from late-stage research through the clinical phases of the drug development process.  The candidate should be familiar with FDA guidance documents.  The position requires adaptability, excellent planning, organization and communication skills, as well as the ability to work in a fast-paced, team-oriented, environment.

 Minimum Required Education and Experience

  • PhD in chemical or biological sciences such as Biochemistry, Immunology, Cell Biology, Chemistry, Molecular Biology or similar, or the equivalent in-lab experience.
  • Minimum of 4 years relevant bioanalytical experience in biotech, CRO or pharmaceutical company developing de novo PK and/or ADA assays for the bioanalysis of biological drug candidates.
  • Demonstrated experience in the development and validation of bioanalytical methods utilizing various analytical technologies and/or assay formats, including a deep understanding of the underlying scientific principles.
  • Previous experience with gene therapies, oligonucleotides, PCR/qPCR, AAV vectors, and/or biodistribution and viral shedding studies considered a plus.
  • Detailed knowledge and understanding of current industry guidance and whitepapers related to regulated bioanalysis.
  • Practical understanding of GLP/OECD regulations and the ability to apply them daily.
  • Ability to provide clear instructions to direct in-lab scientific staff and to confirm instructions were followed as described.
  • Ability to clearly and concisely convey analytical results in written, oral, and electronic formats.
  • Proven ability to manage and coordinate multiple complex projects simultaneously.
  • Adept at following oral and written instructions with the ability to confirm that processes are followed, including adherence to all standard operating procedures.
  • Works with integrity and upholds organizational goals and objectives.
  • Treats others with respect and consideration, accepts responsibility for their own actions, follows through on commitments, asks for and offers help when necessary.
  • Effective communication skills, both oral and written.

Our laboratory runs on a fully electronic platform.  Successful candidates will enjoy and be adept at working with technology and computer-based systems.  At AIT Bioscience, we value you as a person, support your personal growth and development, and want you to succeed.  This opening is a first-shift position, with flexibility needed to occasionally pivot to alternate hours as directed.  If you are a qualified candidate and excited about the opportunities for success and growth we offer, please apply and submit your resume and cover letter with desired salary range.

AIT Bioscience
  • Apply Now

  • Sign Up For Job Alerts

  • Share This Page

.
AIT Bioscience About Us Services Quality Management Resources News Contact Us Request a Quote Search