Research Analyst I

Job Overview

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 (bDNA) 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

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
• Absorb and maintain study specific inventory of consumables with oversight
• Write both study and non-study deviations with minimal oversight
• Actively participate in process improvement initiatives with oversight
• Develop critical thinking, troubleshooting and time management skills aligned with needs of the operational area
• Assist in execution of routine sample analysis studies with oversight
• Assist in execution of method validation projects with oversight as needed
• Operate laboratory instruments with complete oversight
• Assist with data analysis in appropriate software for at least one analytical platform

Job Requirements

• Education: Minimum of a Bachelor’s degree (BA/BS) or equivalent experience.
• No previous experience required
• 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.

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.

Charles River

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.

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