Senior Project Scientist

For over seven decades, Charles River has united its workforce to facilitate the discovery, development, and secure production of innovative drug therapies. By becoming part of our team, you will significantly influence the health and wellness of individuals worldwide. Regardless of whether your expertise lies in life sciences, finance, IT, sales, or another field, your abilities will be crucial to our mission. In exchange, we will support you in cultivating 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 is essential for evaluating test substances by delivering quantitative bioanalytical assessments of drugs in biological fluids and tissues, encompassing both regulated and non-regulated studies, including preclinical safety assessments, pharmacokinetic/pharmacodynamic investigations, and clinical trials. Team members are involved in the development and validation of quantitative LC/MS/MS methodologies, sample analysis, and the interpretation and reporting of data using validated systems. This role also entails the creation of sample extraction techniques, rapid LC separations, and the use of laboratory robotics to improve the turnaround time for bioanalytical results. Additionally, staff members are well-versed in GxP applications and relevant SOPs, ensuring adherence to study protocols for accurate documentation of methods, procedures, and outcomes for study reports and regulatory submissions. Please note that this position does not involve laboratory work.

Key Responsibilities:

• Oversee a portfolio of sample analysis projects, ensuring deadlines are met within a specific operational area with minimal supervision.
• Conduct reviews and approvals of data with limited oversight for final scientific and technical decisions.
• Gain an understanding of compliance requirements to address quality assurance audit findings in relevant software.
• Assist in completing laboratory investigations, troubleshooting assays, and addressing quality observations with minimal guidance.
• Support problem-solving for technical and regulatory challenges independently.
• Review study plans, protocols, and amendments.
• Engage in Sponsor visits and tours with minimal oversight.
• Provide expertise in developing and validating quantitative and qualitative methods and procedures within a defined scope.
• Perform data analysis independently using appropriate software.
• Enhance critical thinking, troubleshooting, and time management skills aligned with operational needs.
• Communicate effectively with peers, supervisors, and team members.
• 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 as needed.
• Collaborate across operational areas to meet timelines and deliver quality data.
• Document all procedures, materials, and results in compliance with applicable regulatory standards.
• Draft, review, and approve deviations with minimal oversight.
• Maintain a comprehensive understanding of regulatory and GXP requirements, industry standards, and company SOPs.
• Manage a small portfolio of research projects, including method development and validation, ensuring timelines are adhered to.
• Recognize method and data issues and communicate them to management to mitigate study impacts.
• Provide support to team members as required.
• Participate in internal process improvements and presentations.
• Perform other 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 of relevant experience; 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 across all organizational levels.
• Basic proficiency with Microsoft Office Suite.
• Computer skills aligned with essential functions, including the ability to learn validated systems.
• Willingness to work extended hours, including evenings and weekends, as needed.
• Ability to operate under specific time constraints.

The compensation range for this role is between $95,000 and $105,000 annually. Please note that salaries within this range may vary based on experience, skills, education, certifications, and location.

About Charles River:
Charles River is a leading early-stage contract research organization (CRO) dedicated to supporting our partners in expediting preclinical drug development through exceptional safety assessment services, advanced facilities, and expert regulatory guidance. Our experienced team is equipped to design and execute programs that anticipate challenges and streamline the journey to market. Each year, we conduct numerous investigational new drug (IND) programs within our Safety Assessment facilities.

At Charles River, we are committed to enhancing the quality of life through our scientific endeavors. Our mission, combined with our commitment to excellence, drives us to improve the health and well-being of individuals globally.