Bioanalytical Principal Investigator I-III Job at Immunologix Laboratories, Tampa, FL

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  • Immunologix Laboratories
  • Tampa, FL

Job Description

Responsibilities

The Principal Investigator:

  • manages regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker studies.
  • communicates the progress/study updates directly with sponsors via email and virtual meetings.
  • Ensures the bioanalytical studies meet all the requirements of the study protocol, internal SOPs, and appropriate regulations.
  • Collaborate with internal support/quality groups (QC, QA, etc) to ensure the scientific integrity of the study documentation, data, and report are of the highest quality.
  • Provides exceptional client experience via clear communication and on-time delivery of data.

Qualifications

  • Experience working in a GxP environment managing plate-based, ligand binding (PK, ADA, and/or biomarker) assays or cell-based (NAb) assays is required.
  • Ability to independently complete documentation in support of bioanalytical test methods that adheres to relevant SOPs and lab practices.
  • Expertise and knowledge of bioanalytical laboratory procedures and practices.
  • Knowledge of industry practices for relevant bioanalytical analysis.
  • Familiarity with Watson LIMS.
  • Ability to analyze, interpret, and present bioanalytical/biomarker data.
  • Study management experience including attention to detail, excellent oral and written communication skills, and ability to multitask with excellent time management.
  • Must work effectively within teams and with clients to meet objectives under time constraints.

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