Job Information
Charles River Laboratories Senior Associate Scientist- Project Scientist, Analytical Chemistry in Cleveland, Ohio
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 a Senior Associate Scientist for our Analytical Chemistry Team at our Safety Assessment site located in Cleveland, OH .
The analytical chemistry discipline is responsible for the analysis of dose formulations according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. The team develops and validates methods using a variety of instruments and platforms, with an emphasis on high performance liquid chromatography. The team assures that mixtures of test article with carrier are prepared at the proper concentration, are homogeneous, and are stable. In addition, the team is often involved in investigations and issues that are related to formulations and chemicals used on study.
Essential Functions (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a
single operational area with oversight
Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area
Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight
Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations
Assist in problem solving for technical and/or regulatory issues with oversight
Responsible for writing and preparing study plans/protocols/amendments with minimal oversight
Participate in Sponsor visits/tours with minimal oversight
Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight
Perform data analysis using appropriate software 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
Function as a liaison, maintaining timely and frequent communication between CRL and
Sponsor/Client/SD with minimal oversight
Ensure scientific integrity of studies with minimal oversight
Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight
Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Write, review and approve deviations with oversight
Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area
Effectively manage a small portfolio of research projects including method or assay development and validation while ensuring timelines are met in a single operational area with oversight
Performs all other related duties as assigned
The pay range for this position is 75K-78K. 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:
Bachelor's degree (BA/BS) with 5-7 years of relevant working experience. Master's degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Ability to communicate verbally and in writing at all levels inside and outside the organization
Basic familiarity with Microsoft Office Suite
Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
Ability to work under specific time constraints
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 supported the development of 86% of the drugs approved by the FDA in 2021.
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.
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.
For more information, please visit www.criver.com.
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