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

Job description  

AIT Bioscience provides expert bioanalytical assay services for small molecule, large molecule, and gene therapy biotherapeutic and biologic drug programs from early discovery to IND enabling toxicology through clinical studies to NDA/ANDA/BLA filing.  Our processes & systems were designed from the ground up by veteran industry experts who thought it was time to approach bioanalytical processes differently.  With years of experience in quantitative bioanalysis and drug development support for small biotech and large Pharma companies, our scientific team spent months evaluating the issues that plague current CROs in order to identify a more efficient way to conduct business in a regulatory setting.  Our "greenfield" solution: a paperless environment that assures correctness from one step to the next.  Instead of addressing issues uncovered in data review after the fact, AIT Bioscience employs novel electronic systems that detect and resolve potential deviations and errors in real time.

 

PURPOSE

The Director of Method Development, Ligand Binding Assays, is a key company role.  The director will provide scientific, technical, and strategic leadership and oversight of bioanalytical science deliverables including data and methods.  The individual will play a pivotal role in supporting AIT sponsored large molecule drug development and safety projects from late-stage research through all later phases of the drug development process in the Ligand Binding Assay (LBA) lab. The individual is expected to have a strong scientific career path and demonstrated expertise in the field of immunoassay design, development, troubleshooting, qualification and validation along with experience in cell therapy and gene therapy.  The candidate must have excellent interpersonal skills and will work closely with representatives from pharmaceutical, biotechnology, and other sponsoring organizations both in a scientific and business development capacity. The candidate must be familiar with FDA guidance documents and industry white papers. The position requires adaptability, excellent planning, organization and communication skills, as well as the ability to work in a fast-paced, team-oriented, environment.  The individual will have a leadership role and will provide expert guidance that will drive the company forward in a competitive business environment.  The director will have the opportunity to exceed key company performance goals, to change the direction of the company as industry needs shift, and to provide a collaborative and collegial work environment that provides meaningful long-term employment to the scientific and supporting staff.

 

Essential Functions

  • Provide scientific leadership in the development, qualification and validation of immunogenicity assays (anti-drug assays), pharmacokinetic (PK) immunoassays and biomarker immunoassays for both preclinical and clinical studies for large molecule drug candidates and gene therapy programs.
  • Develop scientific services that support cell and gene therapy programs.
  • Review immunoassay methods, validation plans, study reports and SOP's.
  • Review and approve data and effectively communicate with sponsors.
  • Recognize and respond to changes and trends in the industry that position the company to capitalize on these opportunities.
  • Develop a leadership role within the American Association of Pharmaceutical Sciences (AAPS).
  • Present scientific data and strategic plans to senior leadership or partners, as well as at external conferences and regulatory meetings.
  • Produce original peer-reviewed publications.
  • Provide expert scientific commentary within a business development setting that results in study authorizations.
  • Provide guidance and lead in the career development of scientific staff.
  • Recruit and hire key staff.
  • Devise and execute a plan to retain key staff over the long term.
  • Oversee routine internal performance and troubleshooting of bioanalytical assays.
  • Work independently, directly and effectively with functional disciplines (research, pharmacology/toxicology, facilities, IT and clinical and technical operations) to move project forward.
  • Evaluate and implement new bioanalytical methods and technologies to solve challenging bioanalytical issues.
  • Represent non-clinical development group at core teams and other cross functional initiatives as needed.
  • Keep current with changing FDA and EU regulatory requirements for bioanalysis.

 

 

Minimum Required Education And Experience

 

  • Ph.D., or MS in biological sciences such as Immunology, Cell Biology, Biochemistry, Molecular Biology or similar.
  • Minimum of 12 years relevant experience in biotech, CRO or pharmaceutical industries around immunoassay development supporting preclinical and clinical studies.
  • Previous management experience required.
  • Strong immunoassay background with experience on ligand binding, immunogenicity, and enzyme/cell-based neutralization assays. Experience with biomarker assays is a strong plus.
  • A publication record is desirable that is immunoassay related.
  • Experience in developing immunoassays that meet performance requirements using different technologies including ELISA, MSD, Gyros, Ella, Quanterix or similar.
  • Excellent writing and editing skills are essential, including highly developed computer skills using Microsoft Word, Excel, PowerPoint, SoftMax Pro or similar.
  • Previous experience in gene and cell therapy highly desirable.
  • Experience in preparing documents for inclusion in regulatory submissions.
  • Ability to complete documentation per GLP (Good Laboratory Practices) requirements.
  • Ability to adhere to SOPs (Standard Operating Procedures).
  • Ability to take initiative, risk and to think outside the box in order to produce and offer new or novel scientific service offerings.
  • Ability to build and foster cross-functional collaborations both internally and externally.
  • An expert in Watson, LIMS and electronic management of data is preferred.
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