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

Bioanalytical Chemistry supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation and reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques, rapid LC separations, and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxP’s and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.

JOB QUALIFICATIONS

• Bachelor’s degree or equivalent with 8-10 years of relevant experience. Between 3-4 years of management experience require
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• LCMS Experience Required
• MRM Experience Required
• CRO Experience Preferred
• Ability to communicate verbally and in writing at all levels inside and outside the organization
• Basic familiarity with Microsoft Office Suite
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
• Ability to work under specific time constraints

• Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees
• Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong
• Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics
• Assist with providing costing estimates for components of applicable studies
• Provide short- and long-term solutions that support continuous improvement
• Develop and maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
• Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements
• Establish and review Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures
• Develop and maintain contemporaneous knowledge of regulatory requirements\
• Effectively plan, assign and direct work within one operational area with expanded scope and/or complexity
• Monitor performance metrics for operational area
• Function as a Principal Investigator, Individual Scientist, and/or Project Scientist as required by operational area or resourcing need
• Skillfully oversee the design, conduct, interpretation and reporting of studies
• Effectively utilize project management systems
• Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs
• Performs all other related duties as assigned