Senior Project Scientist

Join Our Team at Charles River

For over 75 years, Charles River has been at the forefront of assisting in the discovery, development, and safe production of innovative drug therapies. By becoming part of our organization, you will contribute significantly to the health and well-being of individuals worldwide. Regardless of your background—be it in life sciences, finance, IT, sales, or another field—your expertise will be invaluable to our mission. In return, we are committed to helping you cultivate a fulfilling career.

Position Overview

We are currently looking for a Senior Project Scientist specializing in Bioanalysis LCMS to join our Bioanalytical Chemistry Team.

The Bioanalytical Chemistry division plays a crucial role in evaluating test compounds by delivering quantitative analysis of drugs in biological fluids and tissues. This encompasses both regulated and non-regulated studies, including preclinical safety assessments, pharmacokinetic/pharmacodynamic evaluations, and clinical trials. Team members engage in the development and validation of quantitative LC/MS/MS methodologies, conduct sample analyses, and interpret and report data using validated hardware and software systems. Responsibilities also include developing sample extraction techniques, optimizing rapid LC separations, and utilizing laboratory robotics to enhance the efficiency of bioanalytical data delivery. Knowledge of GxP regulations and adherence to standard operating procedures (SOPs) is essential, as is accurate documentation of methods, procedures, and results for study reports and regulatory submissions. Please note that this role does not involve laboratory work.

Key Responsibilities:

• Manage a portfolio of sample analysis projects, ensuring adherence to timelines with minimal supervision.
• Review and approve data, making final scientific and technical decisions independently.
• Understand compliance expectations and address quality assurance audit observations effectively.
• Assist in laboratory investigations, assay troubleshooting, and quality observations with minimal oversight.
• Independently resolve technical and regulatory issues.
• Review study plans, protocols, and amendments.
• Participate in Sponsor visits and tours, providing expertise in method development and validation.
• Conduct data analysis using appropriate software independently.
• Develop critical thinking and time management skills aligned with operational needs.
• Communicate effectively with peers, supervisors, and teams.
• Act as a liaison, maintaining timely communication between Charles River and Sponsors/Clients.
• Ensure the scientific integrity of studies independently.
• Function as a Principal Investigator, Individual Scientist, or Study Director.
• Collaborate across operational areas to meet timelines and produce quality data.
• Document all procedures, materials, and results in compliance with regulatory standards.
• Write, review, and approve deviations with minimal oversight.
• Understand regulatory and GxP requirements within the operational area.
• Manage a small portfolio of research projects, ensuring timelines are met.
• Recognize method and data issues and communicate them to management.
• Support staff members as needed.
• Participate in internal process improvements and presentations.
• Perform additional related duties as assigned.

Qualifications:

• Bachelor's degree (BA/BS) with 7-9 years of relevant experience; Master's degree (MS) with 3-4 years; or Doctorate degree (PhD) with 1-2 years of relevant experience.
• Experience with LC/MS/MS is required.
• An equivalent combination of education and experience may be considered.
• Strong verbal and written communication skills at all organizational levels.
• Familiarity with Microsoft Office Suite.
• Proficient computer skills, including the ability to learn validated systems.
• Willingness to work extended hours as needed.
• Able to work under specific time constraints.

Compensation:

The salary range for this position is competitive and commensurate with experience, skills, education, and certifications.

About Charles River:

Charles River is an early-stage contract research organization (CRO) dedicated to supporting clients throughout the drug development process. Our extensive portfolio of discovery and safety assessment services, both GLP and non-GLP, enables us to assist clients from target identification through preclinical development. With over 20,000 employees across 110 facilities in more than 20 countries, we are strategically positioned to address our clients' unique challenges and enhance their productivity.

At Charles River, we are passionate about improving the quality of life through our work. Our mission, commitment to excellent science, and strong sense of purpose guide our daily efforts to enhance global health and well-being.