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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