Research Scientist 1, Bioanalytical Chemistry

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

The incumbent will serve as a scientific team member in the conduct of preclinical and clinical research studies of basic to moderate complexity. Responsibilities include study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Serve as a Project Scientist for the development and validation of analytical assays. 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, Individual 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.
• Review, interpret, integrate, and present data on assigned studies.
• Critical review of analytical results and batch analysis as necessary.
• Design, develop, and validate novel assays within the appropriate scientific discipline.
• Collaborate effectively with on-site management, operations, and technical staff.
• 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.
• 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 study planning, scheduling, conduct and reporting.
• Provide prompt verbal or written communication with Sponsors on study related business.
• Mentor junior staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and execution of validation studies.
• Review reports for peers as needed.
• Attend scientific meetings, conferences and training courses to enhance job and professional skills.
• Contribute to testing of new analytical technologies or introduce improvements in existing technologies

The pay range for this position is $100,000 to $115,000 annually USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location

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 PhD/DVM preferred.

Experience: Minimum of 6 years related experience in the development and/or validation of assays is preferred (i.e.: chromatographic bioanalytical, flow cytometry, receptor occupancy, cell-based assays, mammalian cell culture, PBMC isolations, ELISPOT, ligand binding assays, biomarkers as appropriate).

• 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. Experience in a contract research organization is preferred.
• Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, Graphpad Prism, 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.

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 .... 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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