Method Development Principal Investigator/Project Manager (Ligand Binding Assay)
- - LBA
- Indianapolis, IN, USA
- Full Time
AIT Bioscience (AITB) 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 bioassay support development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.
AITB is the first and only CRO in the world 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.
To support our continued growth, AITB is seeking an experienced Method Development Principal Investigator/Project Manager (Ligand Binding Assay) for our Indianapolis laboratory. The Principal Investigator is responsible for Ligand Binding Assay development and validation studies.
Summary of Job Responsibilities
- Serves as a Responsible Scientist or Principal Investigator (PI) for non-regulated and GLP-regulated ligand binding assay development and validation studies.
- Ensures client Ligand Binding Assay (LBA, immunoassay) programs meet AIT Bioscience, sponsor, and regulatory requirements.
- Serves as the scientific point of contact for the sponsor.
- Develops immunoassay methods, reviews protocols and sample analysis plans.
- Reviews data alongside the method development team to ensure methods are ready for validation.
- Approves validation methods and reviews sample analysis methods.
- Independently reviews and approves raw data.
- Reviews and approves reports for scientific accuracy and completeness.
- Takes accountability and demonstrates responsibility regarding scientific study conduct.
- Actively promotes collaboration within and across groups.
- Provides appropriate coaching and recognition to team members.
- Promotes a positive impression of AIT Bioscience internally and within the industry.
- Plans, prioritizes, and manages workload for large and complex projects.
- Assists in business development activities.
Education / Qualifications
- BSc, MS, PhD or equivalent in science or related field.
- 3 or more relevant publications/poster presentations/podium presentations.
- Experience conducting method development to support immunogenicity assays, pharmacokinetic (PK) assays and biomarker assays in a pharmaceutical or contract research organization (CRO) environment under FDA/EMA regulations
- 5+ years of immunoassay (ligand binding assay) development experience. This means you can take a keyword and then develop and validate an immunoassay from scratch and this work is published/referenced or presented.
- 3+ years as a study director or PI in a GLP compliant lab.
- Knowledge of global regulatory bioanalytical agency guidelines.
- Experience with ELISA and MSD® or Gyrolab® technologies preferred.
- Experience of Watson® LIMS preferred.
- Excellent communication and interpersonal skills.
- Proven ability to prioritize and manage time.
- Excellent attention to detail.
- Able to utilize word processing, database, spreadsheet, and specialized software.
Due to the unique systems employed by AIT Bioscience, this person must also have a high level of competency in computer systems and be comfortable with the concept and practice of operating in a paperless environment. The department has been an early adopter in the use of electronic laboratory note books for regulated bioanalysis. The development of optimal workflows for LBA using electronic record keeping is ongoing and an important facet of this position.
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