Job Description

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

Serve as a scientist in the conduct of assigned nonclinical or clinical research studies of basic to moderate complexity, to include method development, study management, interpretation, and reporting of study data, and assuring the regulatory compliance of these projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• 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. 
• 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. 
• Execute review and approval of data for final scientific/technical decisions within a single operational area, with minimal oversight.
• Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software, with minimal oversight. 
• Responsible for writing and preparing study plans/protocols/amendments/reports independently. 
• Participate in sponsor visits/tours, with minimal oversight. 
• Independently ensure scientific integrity of studies. 
• Write, review, and approve deviations, with minimal oversight.
• Full understanding of regulatory and GLP requirements, industry standards, and company SOPs within one operational area. 
• Effectively manage a small portfolio of projects, including method development and validation studies while ensuring timelines are met in a single operational area, with minimal oversight. 
• Provide support to staff members as required by operational areas, as needed. 
• Actively participate in internal process improvements, presentations, and harmonization efforts.
• Attend scientific meetings, conferences, and training courses to enhance job and professional skills.
• Partner with other MD Scientists, Principal Investigators, Operations Chemists, and Management to ensure method scope and performance meet the client’s requirements.
• Assist in assay troubleshooting, with a sense of urgency.
• Contribute to the development of novel assays that evolve CRL’s current analyte and/or platform offerings. 
• Consideration of operational efficiency and cost when developing methods.
• Provide technical and scientific guidance to the research staff.
• Contribute to presentations/posters/manuscripts and attend scientific meetings, conferences and training courses to enhance job and professional skills.
• Perform all other related duties as assigned.

Job 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. highly preferred.
• Experience: Minimum of 6 to 7 years related experience with a Bachelor’s degree, 3 to 4 years with a Master’s degree, 0 to 2 years with a Ph.D.; in the contract research, academic, or pharmaceutical industries.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: N/A.
• Other: Hands-on experience with bioanalytical sample extraction techniques and the use of LC-MS/MS instrumentation is required.   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.

PHYSICAL DEMANDS:

• Must be able to lift, move, manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.
• Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
• Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
• Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.
• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Move about inside the work area to access file cabinets, office machinery, etc.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT:

• General office and lab working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, and work with biohazards.
• The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions.
• The noise level in the work environment ranges from low to moderate depending upon the task being performed.

Compensation Data

The pay range for this position is $85,000 - $95,000 USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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