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 The QC Scientist I should possess broad knowledge of quality control testing and working in a GMP laboratory environment. Participates in assay development qualification/validation projects. Responsible for writing and review of reports, deviations, CAPAs and OOS documents. Participates in testing using qualified/validated methods and training of junior staff. Positions requires some knowledge and experience in cell culture, ELISA, gel-electrophoresis, Western blot, PCR and other virus-based assays. Key Responsibilities and Duties: * Knowledgeable in qPCR, ddPCR, and related methods, for viral based products. * Knowledgeable in cell culture and cell-based assays for vial products (Plaque assay, TCID50 etc.) * Experience performing ELISAs, gel-electrophoresis, Western Bot * Experience working in a GMP lab environment. * Experience in method development and troubleshooting as well as qualification and validation of QC methods assays. * Attend departmental meetings and provide clients with periodic progress updates. * Demonstrated ability to analyze and interpret data. * Ability to support multiple projects concurrently. * Strong organizational, analytical, and problem-solving skills * Conduct literature searches and design, develop, optimize and execute method development. * Assist in writing and review of method development reports, SOPs, protocols, reports. * Experience writing Deviations, CAPAs and OOS documents. * Experience working in a Quality Control GMP testing lab. * Other responsibilities as needed Job Qualifications * BS/MS/PhD in a biological science or equivalent experience * 3-5 years of experience in a Quality Control GMP laboratory environment * Extensive experience with assay development and qualification of methods * Knowledge of ICH/USP and FDA guidelines * Excellent verbal and written communication skills * Team Player * Demonstrates Integrity and Respect * Delivers Results Compensation Data The pay range for this position is $68,712 to $91,616. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location. 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 characterization, 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 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 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, or national origin, veteran or disability status. 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. For more information, please visit www.criver.com. 227968