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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