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.
This role shall report to the CBA Operations Manager and the main duties & responsibilities shall be to assist the Department Manager and/or the Scientist in the following:
Core duties shall include:
Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Executes scientific testing strategies and studies. May participate in development as part of team. May lead assay research, assay validation or study conduct, or is involved in preparation of material (e.g. protein, nucleic acid, cells, etc.). Reviews and interprets study data, communicates results to clients and writes final reports. Ensures compliance with protocols and all applicable SOPs. Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed. Contributes to specific dataset interpretation, or when appropriate answering questions from regulatory authorities. For singular focus of Chemistry or Biology disciplines, refer to specified role on job architecture.
Job Qualifications
The following are minimum requirements related to the Senior In-Vitro Bioassay Analyst position.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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 80% of the drugs approved by the FDA in the last five years.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.
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