Study Director

Role Summary

The Research Scientist (RS) will be engaged in serving as the single point of study control and overall planning and conduct of the study in accordance with applicable regulatory guidelines and contemporary scientific practice. Additionally, the RS will ensure that all Good Laboratory Practices (GLP) are met, and that the outcome of the study is valid and reliable. This role requires experience with LBA method development, GLP-compliant method validation, and GLP-compliant sample analysis, including MSD/ELISA and ADA is a must. This includes experience with sponsor interaction, protocol development, and data interpretation experience as well. This is an exempt role with no supervisory responsibility.

Role Responsibilities

• Serve as the Principal Investigator/Study Director/Bioanalytical Monitor for internal and external studies. Has overall responsibility for the technical conduct of the study, interpretation and reporting of results in accordance with regulatory agencies, protocols, amendments, methods, and standard operating procedures.
• Develop protocols and ensures that the protocol, and any amendments, are approved and followed.
• Ensure all experimental data, deviations, and unanticipated events are accurately recorded and any corrective actions needed are documented.
• Establish and maintain relationships with industry and scientific thought leaders through effective communication and scientific expertise.
• Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of the study
• Develop NBS’ scientific knowledge and expertise in gene and cell therapy.
• Drive efficiencies through automation/new technologies in sample preparation, analysis and reporting.
• Write and review reports and SOPs.
• Communicate with management and Sponsors regarding project issues, changes, and requirements.
• Mentor and guide junior scientist and technicians.
• Other duties as assigned.

Role Requirements

• Bachelor’s degree or equivalent in a scientific related discipline required. A Master’s degree or Ph.D. is preferred.
• Minimum of 10 years of related scientific experience. A combination of education and experience may be accepted
• Strong background in immunology and plate-based assay development with experience in bioanalytical method validation.
• Experience with a wide variety of ligand binding assays for biomarker, protein quantification, and anti-drug antibody analysis.
• Experience with regulated studies along with a solid understanding of study design and protocols
• Knowledge of GLPs and other federal regulations relating to the company
• Solid understanding of laboratory operations and data collection
• Self-starter, able to prioritize work, and work efficiently with minimal supervision
• Excellent analytical and problem-solving skills
• Excellent verbal and written communication skills; ability to design, interpret, and present scientific data in a team environment is preferred
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.