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Form of workFor 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
BASIC SUMMARY:
Serve as an expert scientist in the conduct of assigned nonclinical and clinical large molecule bioanalysis research studies at all levels of complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects, as appropriate. Provide support and direction for one or more functional areas of expertise critical to the business objectives of Charles River Laboratories.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Function effectively as a Project Scientist in the direction and execution of assigned studies in compliance with GLP or other applicable regulations for the conduct of nonclinical and clinical research.
• Participate in the proposal management and bid development process, serving as a key scientific contact for new business generated from established business relationships. Oversee specialty programs and serve as a key scientific contact for new business generated from established business relationships. Provide strategic advice for effective program management and project coordination.
• Design specialty nonclinical and clinical programs in area of expertise. Can develop and validate plate-based immunoassays (ELISA, MSD) for PK, biomarker, and immunogenicity (ADA, NAb) testing according to FDA/ICH/EMA guidelines.
• Independently interpret data for studies, provide scientific rigor, effectively integrate supporting data, and consistently prepare high-quality reports.
• Serve as project coordinator and function as a primary contact for key sponsors, coordinating proposal requests, site visits, and responses to client issues.
• Oversee sponsor interactions, including scientific program development, consulting on study and program design, scheduling, conduct, and reporting. Communicate and provide guidance for client issue resolution and interaction concerning regulatory issues.
• Provide oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation. Provide scientific expertise in study conduct, design, and interpretation.
• Review protocols, reports, and scientific documents of others as needed.
• Provide technical and scientific guidance to research staff.
• Design and/or implement new experimental approaches to support studies and develop new business niches for Charles River Laboratories.
• Serve as a mentor to other scientists.
• Function as departmental representative for interdepartmental communications and initiatives as required.
• Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Present abstracts/posters at national meetings, when appropriate, to maintain a scientific presence and visibility in areas of individual expertise.
• Direct activities of assigned group(s) to ensure effective performance of function.
• Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
• Assist in directing the development and communication of departmental systems, SOPs, policies, and procedures. The position does not have any direct reports but is considered a leadership position with development opportunities.
Job Qualifications
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 Ph.D./D.V.M. preferred.
• Experience: Minimum of 13+ years related experience in the contract research, academic, or pharmaceutical industry.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
The hiring range for this position is $135k-$150k. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. This position is part of our leadership team but does not have any direct reports. This position is 100% onsite at our Skokie, IL location but does allow for 2 days/remote (hybrid).
About Safety Assessment
Charles 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 River
Charles 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 supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment Opportunity
Charles 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 [email protected]. 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.
