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.Essential Functions (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues with minimal oversight
Effectively develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area with minimal oversight
Independently perform data analysis in appropriate software for a majority of analytical platforms within an operational area
Independently operate laboratory instruments including their respective software applications for 1-2 analytical platforms within an operational platform
Develop 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
Able to recognize method and/or data issues and communicate them to management to minimize study impact independently
Independently prepare summary of method development data
Write both study and non-study deviations with minimal oversight
Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area
Independently lead the lab staff in the completion of method validation studies
Provide support to staff members as required by operational area as needed
Actively participate in internal process improvements, presentations and harmonization efforts
Performs all other related duties as assigned
The pay range for this role is $80-85K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and locationJob Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Bachelor's degree (BA/BS) with 7-9 years of relevant working experience. Master's degree (MS) with 3-4 years of relevant working experience. Doctorate degree (PhD) with 1-2 years of relevant working experience
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
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
About Safety AssessmentCharles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.About Charles RiverCharles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.Equal Employment OpportunityCharles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitmentUS@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.For more information, please visit www.criver.com.224995