Bioanalytical Principal Investigator I-III

ResponsibilitiesThe 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.QualificationsExperience 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.

Created: 2025-10-01