For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

JOB SUMMARY

Charles River Laboratories is seeking a Research Scientist to join our Laboratory Sciences group within our Safety Assessment site located in Shrewsbury, MA. The incumbent will serve as a scientific team member in the conduct of preclinical and clinical research studies at all levels of complexity. Responsibilities include study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic assays, Luminex, Bioplex, MSD, Quanterix, ProteinSimple). This individual would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary scientific contact for key clients and the on-site support of their programs.

QUALIFICATIONS:

• Education: Bachelor’s degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master’s degree (M.S./M.A.) or PhD/DVM preferred.

Experience: Minimum of 6 years related experience in the development and/or validation of biomarker, PK and ADA assays is preferred (eg: ligand binding assays, enzymatic assays, Luminex, Bioplex, MSD, Quanterix Simoa, ProteinSimple Ella). Experience in a contract research organization is preferred.

• Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations. Experience with Watson LIMS (preferred).

• Function independently as a Project Scientist, Principal Investigator, Contributing Scientist in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and clinical research. Provide scientific expertise in study conduct, design, and interpretation.
• Participate in and coordinate all phases of the study planning process with appropriate departments.
• Develop assays, generate high-quality laboratory method, protocols, amendments, reports, and facilitate appropriate changes to study design for assigned projects and programs.
• Review, interpret, integrate, and present data on assigned studies.
• Writes and edits draft or final reports that document all study related procedures and results.
• Analyze scientific problems, troubleshoot analytical methods and technical issues.
• Function independently as the point of contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
• Provide prompt verbal or written communication with Sponsors on study related business.
• Mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and execution of validation studies.
• Provide technical and scientific guidance to the research staff.
• Contribute to testing of new biomarker technologies or introduce improvements in existing technologies.