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 Principal Scientist/Senior Scientist, Molecular Biology will provide scientific, technical and strategic leadership and oversight of bioanalytical science deliverables (data and methods) and play a pivotal role in supporting AIT sponsored gene therapy projects from late-stage research through all later phases of the drug development process.  The individual is expected to have strong scientific know-how and demonstrated expertise in the field molecular biology and PCR design, qPCR and bDNA assay development, troubleshooting, qualification, and validation.  The candidate must have excellent interpersonal skills and will work closely with representatives from pharmaceutical, biotechnology, and other sponsoring organizations. 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.

 

Essential Functions

  • Lead in the development of molecular biology services (qPCR and bDNA) in a CRO setting.
  • Design primers.
  • Evaluate and implement new bioanalytical methods and technologies to solve challenging bioanalytical issues.
  • Select and onboard molecular biology instruments.
  • Author assay methods, validation plans, study reports and SOP's.  Review and approve data and effectively communicate with sponsors.
  • 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 projects forward.
  • Participate in generation of bioanalytical reports and sections for regulatory filings.
  • 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.
  • Keep current with changing FDA and EU regulatory requirements for bioanalysis.
  • Develop a molecular biology service program within the confines of an electric laboratory notebook (ELN) setting.

 

 

Minimum Required Education and Experience

 

  • Ph.D., MS or BS in biological sciences such as Immunology, Cell Biology, Biochemistry, Chemistry, Molecular Biology or similar.
  • Minimum of 5 years relevant experience (7 years with BS) in biotech, CRO or pharmaceutical assay development.
  • Expertise with oligonucleotides.
  • Expertise with biodistribution and viral shedding studies.
  • Experience with AAV preferred.
  • Previous experience in gene and cell therapy highly preferred.
  • Previous experience in drug development or drug safety highly preferred.
  • Prior experience managing and developing scientists in molecular biology assay development.
  • Demonstrated expertise in the development and validation of molecular biology techniques including, but not limited to, PCR, quantitative PCR (qPCR), real-time PCR, HPLC and hybridization assays (publications/poster presentations).
  • Working or conceptual knowledge of assay development and validation of ELISA, MSD, LC/MS and HRMS methods.
  • A publication record is preferred, especially molecular biology related.
  • Ability to complete documentation per GLP (Good Laboratory Practices) requirements.
  • Ability to adhere to SOPs (Standard Operating Procedures).
  • Excellent writing and editing skills are essential, including highly developed computer skills using Microsoft Word, Excel, PowerPoint, SoftMax Pro or similar.
  • Exposure to Watson, LIMS and electronic management of data is preferred.
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