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 SALARY: The salary for this position is $70,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays (LBA), such as enzyme-linked immunosorbent assay (ELISA), to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic (PK) assays to measure drug and Immunogenicity assay to measure
anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Other assay types also performed are branched DNA (b DNA) and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery (MSD), Luminex and Gyrolab.
Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies. Essential Functions (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 · Perform data analysis in appropriate software for at least one analytical platform with oversight · Operate laboratory instruments including their respective software applications 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 · Write both study and non-study deviations with oversight · Performs all other related duties as assigned Job Qualifications Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: · Bachelor’s degree (BA/BS) with 3-5 years of relevant working experience.
Master’s degree (MS) with no previous work 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 backssment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety backssment 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 backssment 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 backssment 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 medical 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, interaction, interactionual 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 xyz X@.
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