Previous Job
Previous
Scientist II
Ref No.: 20-00202
Category: Biotechnology
Location: Pearl River, New York
AsScientist 1-3, the incumbent will report directly to the Head of Clinical Immune Assays and be responsible for generating high-quality clinical immunoassay data in a regulated GCLP/GLP laboratory setting to support programs. This includes supporting the pre-clinical assay transfer to clinical testing team, integration of new clinical laboratory immunoassays, support assay validation projects and to monitor assay performance. The incumbent will also work with their manager and colleagues to plan, design and validation of new robotic system activities.

Responsibilities:
  • Work with Head of Clinical Immune Assay to organize and manage the development and qualification/validation of immunoassays to support immunogenicity assessments of vaccine programs.
  • Integrate and establish qualification/validation workflow (IQ/OQ/PQ) with automation robots, such as liquid handler, plate washers, plate readers and other high throughput immunoassay systems.
  • Work with Principal/Senior Scientist in GCLP/GLP compliance, including batch creation for clinical testing, review documentation, audit readiness, maintaining and promoting laboratory safety and compliance.
  • Organize the preparation, handling, filing, and archiving of clinical assay documentation and reports according to SOPs and study requirements.
  • The incumbent should have a knowledge of basic statistical analyses and be able to interpret/communicate statistical results.
  • The incumbent will provide guidance to develop solutions to complex assay challenges and troubleshooting.
  • Establish and oversees monitoring of clinical immunoassay performance.
  • Ensure that the Clinical Assay group's activities are performed safely; and regulated tasks/activities are performed in compliance with GCLP/GLP and Regulatory agency requirements.

Qualifications:
  • A working understanding of assay qualification and validation is preferred.
  • Prior experience in validating, programming and running automated robotic assay platforms and training in a GCLP/GLP environment and other international regulatory guidelines is a plus.
  • A minimum of a Bachelor's degree is required with at least 4+ years of experience, and/or advanced degree Master's with at least 2+ years direct pharmaceutical industry experience with clinical high throughput disciplines GCLP/GLP is preferred.
  • Experience with operating and programming liquid handling robotics platforms (e. g., BioMek, Hamilton, TECAN, Agilent Technologies, CTL and etc) is preferred.
  • Experience in sample management and/or data upload systems such as LIMS is preferred.