Research Scientist/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 specifically requires experience with Proteins and Biomarkers**

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 ensure 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 and/or Protein/Immunogenicity assays.
• 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 scientists 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 of cell and molecular biology, virology, and biochemistry.
• Experience with a wide variety of biochemistry and molecular biology methods for nucleic acid analysis, amplification, qPCR, RT-qPCR, and molecular cloning.
• 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.

Northern Bio is an equal-opportunity employer. We believe in creating an inclusive workplace where diverse perspectives come together to drive innovation. Your unique background, talents, and insights will help us achieve our shared mission.