Research Scientist II, Toxicology

Charles River Laboratories; Shrewsbury (MA); Presencial; USD 100.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus/incentives based on performance

401K

Health and wellness coverage

Paid time off

Descripción de la vacante

Charles River Laboratories in Massachusetts is seeking a senior scientist to conduct nonclinical toxicology studies of moderate to high complexity and manage study design, data interpretation and reporting while ensuring regulatory GLP compliance.

The role includes designing tests, guiding Sponsors, writing protocols and final reports, coordinating study planning, mentoring staff, and communicating results to Sponsors throughout the process.

Formación

• Bachelor’s degree in a scientific field; MS/PhD preferred.
• Experience in contract research, academia, or pharmaceutical industry with GLP awareness.

Responsabilidades

• Designs and/or executes toxicology testing strategies and studies.
• Provides guidance to Sponsors regarding study design and endpoints.
• Writes study protocols and plans.
• Leads all aspects of the study including in-life, data review, and report drafting.
• Ensures PIs and staff are accountable for study components.
• Advises clients on program design and data interpretation.
• Acts as study director in GLP-compliant nonclinical research.
• Coordinates all phases of study planning with appropriate departments.
• Interprets and presents data with minimal supervision.
• Acts as contact for sponsor interaction, proposal management, and scheduling.

Conocimientos

Study management

Toxicology interpretation

Regulatory compliance

Data analysis

Scientific writing

Communication skills

Educación

Bachelor’s degree in a scientific field

MS/PhD preferred

Herramientas

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Descripción del empleo

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 Overview

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

Job Description

• Designs and/or executes toxicology testing strategies and studies.
• Provides guidance to Sponsors regarding study design and study endpoints.
• Writes study protocols and plans.
• Leads and is responsible for all aspects of the study including in-life, data review and interpretation, communication of results to Sponsors, study updates to the Sponsor, and the draft and final reports.
• Ensures that all Principal Investigators, Individual Scientists, and all key study personnel are held accountable for the various study components.
• Provides advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.
• Function independently as a study director in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research.
• Participate in and coordinate all phases of the study planning process with appropriate departments.
• Review, interpret, integrate, and present data on assigned studies with minimal assistance.
• Function independently as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
• Assist in the 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 technical and scientific guidance to the research staff.

Education And Experience Requirements

• 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 8 to 9 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.
• Certification/Licensure: Certification as appropriate for specialty preferred.
• Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. 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.

Work Environment And Physical Requirements

• 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.
• 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.
• This position may require occasional travel.
• The base pay for this position is between $100,000-120,000/yr. 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

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 [e-mail]. 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.