Senior GLP Toxicology Study Director | CRO Scientist

NorthernBio; Muskegon (MI); On-site; USD 120,000 - 170,000; Full time

Job summary

NorthernBio is seeking a Research Scientist/Study Director to oversee non-clinical investigations in a GLP-compliant CRO setting in the United States. The role focuses on study control, protocol generation, data integrity, and regulatory compliance with FDA/OECD/MHLW guidelines.

Ideal candidates have 5–7 years of GLP laboratory experience, a Master’s degree or PhD, and strong scientific writing, communication, and data analysis skills.

Qualifications

• Master’s Degree or equivalent in a related discipline required, PhD preferred.
• 5 years of experience in a GLP-compliant laboratory preferred.
• Experience with peer-reviewed publications, presentations, and scientific writing.
• Knowledge of GLPs (FDA, OECD, and MHLW) and other federal regulations relating to the care of laboratory animals.
• Ability to work extended hours beyond normal work schedule.

Responsibilities

• Represent the single point of control for all aspects of a study while serving as Study Director for non-clinical studies.
• Responsible for the technical conduct of the study as well as for the interpretation, analysis, documentation, and reporting of results.
• Generate protocol and ensure that the protocol, including any changes, are approved and followed.
• Ensure all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
• Ensure that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
• Ensure that Test systems are as specified in the protocol.
• Ensure compliance with the protocol, amendments, and regulatory agencies as identified in the protocol and SOPs.
• Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of a study.
• Interface with Sponsors, Vendors, Contributing Scientists and Principal Investigators.
• Other duties as assigned

Skills

GLP knowledge

Study design

Non-clinical toxicology

Regulatory compliance

Data analysis

Education

Master's degree

PhD preferred

Tools

Microsoft Office

Job description

NorthernBio is seeking a Research Scientist/Study Director to oversee non-clinical investigations in a GLP-compliant CRO setting in the United States. The role focuses on study control, protocol generation, data integrity, and regulatory compliance with FDA/OECD/MHLW guidelines.

Ideal candidates have 5–7 years of GLP laboratory experience, a Master’s degree or PhD, and strong scientific writing, communication, and data analysis skills.