Associate Scientist - Bioanalytical

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

We are seeking an Associate Scientist for our Bioanalytical Chemistry team for our Safety Assessment site located in Ashland, Ohio.

Serve as a scientist dedicated to troubleshooting/validating methods. Work closely with Management, Principal Investigators, Method Development, and Chemist to efficiently progress studies forward and meet sponsor timelines.

Essential Duties and Responsibilities: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

• 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 oversight.
• Effectively develop and validate quantitative/qualitative methods/procedures with limited complexity/scope in one operational area, with 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.
• Develop ability to recognize method and/or data issues and communicate them to management to minimize study impact, with oversight.
• Prepare summary of method development data, with oversight.
• Execute review and approval of data for final scientific/technical decisions within a single operational area, with oversight.
• Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software, with oversight.
• Responsible for writing and preparing study plans/protocols/amendments/reports, with oversight.
• Participate in sponsor visits/tours, with oversight.
• Function as liaison, maintaining timely and frequent communication between CRL and sponsor/client/SD, with oversight.
• Ensure scientific integrity of studies, with oversight.
• Function as a Principal Investigator, Individual Scientist, and/or Project Scientist as assigned, with oversight.
• Write, review, and approve deviations, with oversight. Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Perform all other related duties as assigned.
• Operation Method Validation proficiency and expertise – quick, high quality, complex.
• Need to be able to assess validation results and performance to be able to indicate when issues occur and understand the meaning.
• Execute Proof-of Concept exercises to vet methods.
• Work to address minor method issues in Operations – that may not need a developer’s time.
• Train and mentor RAs to be able to perform method validations.
• Execute transfer method development testing as needed

The pay range for this position is $70-75K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location

Job Qualifications

(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:

• Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline required. Related master's degree (M.S./M.A.) preferred.
• Experience: Minimum of 3-5 years with a bachelor's degree or zero years with a master's degree of related experience.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other: 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(R) Excel, Word, PowerPoint, etc. and with standard laboratory calculations.

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 [email protected]. 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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