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
Charles River Laboratories is seeking a Research Scientist to join our Laboratory Sciences group within our Safety Assessment site located in Shrewsbury, MA. The incumbent will serve as a scientific team member in the conduct of preclinical and clinical research studies at all levels of complexity. Responsibilities include study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic assays, Luminex, Bioplex, MSD, Quanterix, ProteinSimple). This individual would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary scientific contact for key clients and the on-site support of their programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Function independently as a Project Scientist, Principal Investigator, Contributing Scientist in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and clinical research. Provide scientific expertise in study conduct, design, and interpretation.
• Participate in and coordinate all phases of the study planning process with appropriate departments.
• Develop assays, generate high-quality laboratory method, protocols, amendments, reports, and facilitate appropriate changes to study design for assigned projects and programs.
• Review, interpret, integrate, and present data on assigned studies.
• Writes and edits draft or final reports that document all study related procedures and results.
• Analyze scientific problems, troubleshoot analytical methods and technical issues.
• Function independently as the point of contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
• Provide prompt verbal or written communication with Sponsors on study related business.
• Mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and execution of validation studies.
• Provide technical and scientific guidance to the research staff.
• Contribute to testing of new biomarker technologies or introduce improvements in existing technologies.
The pay range for this position is between $100,000 to $110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 PhD/DVM preferred.
Experience: Minimum of 6 years related experience in the development and/or validation of biomarker, PK and ADA assays is preferred (eg: ligand binding assays, enzymatic assays, Luminex, Bioplex, MSD, Quanterix Simoa, ProteinSimple Ella). Experience in a contract research organization is preferred.
• Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations. Experience with Watson LIMS (preferred).
PHYSICAL DEMANDS:
• While performing the duties of this job, the employee is regularly required to talk, hear and work/ type at a computer.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.
WORK ENVIRONMENT:
• General office working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near
toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.
COMMENTS:
• This position may require occasional travel.
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 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 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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
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