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
Have you got recent and proven experience of working in GMP laboratories and a focus on QC within GMP regulations? Do you have knowledge and skills in Environmental Monitoring and assays such as Bioburden, Endotoxin and Sterility? Are you experienced in working in accordance to Pharmacopeia regulations? At our customer site in Stevenage, we are excited to be recruiting for a Scientist with proven experience of working within GMP regulations and a strong microbiology skill set to join our existing established team performing method development, qualification, and tech transfer of assays for our customer. Essential Duties and responsibilities: Lead EMPQ for Graded Area. Perform routine room Environmental Monitoring. Conduct Growth Promotion, Colony Counting, Personnel Monitoring, Surface Monitoring. Perform compendial verification and Product Specific Qualification on Bioburden, Endotoxin, Sterility and Rapid Sterility assays. Act as SME for Bioburden, Endotoxin, Sterility, Rapid Sterility testing and associated regulatory requirements. Effective mentoring of staff. Conduct literature searches. Author method SOP’s and qualification/validation/transfer protocols and reports. Provide testing support for QC as needed (execute test methods in a GMP setting). Train and transfer robust assays for QC testing. Contribute to building a culture of continuous learning/improvement and innovation. Maintain current awareness and contribute to current scientific literature and actively apply new concepts and technologies. Able to work independently to execute new test methods. Rigorously analyse and interpret data. Support multiple projects and strong organisational and problem-solving skills. Skills and Experience
MSc or PhD, preferably in a life science or related discipline preferred. Proven experience of working with a GMP environment, microbiology in biology, virology, molecular biology, cell biology, biochemistry, or suitable field preferred. Maintain current awareness and contribute to current scientific literature and actively apply new concepts and technologies. Preferred working experience in viral gene therapy vectors. Previous biologics contract manufacturing organisation or CDMO experience preferred. Microsoft Office experience (Word, Excel, PowerPoint, etc.). Team-player. Able to work independently to execute new test methods. Able to rigorously analyse and interpret data. Able to support multiple projects and strong organisational and problem-solving skills. What We Offer You
A very comprehensive benefits package from day one, including a generous pension contribution, and flexible health benefits. Access to great discounts via our CREDS discount scheme. Global opportunities and strong career progression. The chance to work on several varied projects and liaise globally and nationally with other business areas. To be able make a difference to health and wellbeing of people. To continue your own career growth. Parental leave. Group Life Assurance and Group Income Protection. Remote GP access 24/7. Well being support and initiatives. Cycle to work scheme. About RightSource (Biologics Testing) The biopharmaceutical industry is growing at an unprecedented pace which is simultaneously changing current testing methodologies. To keep up with the demand, we offer a flexible testing platform which can be deployed on-site at the client site to their exact needs. Our biologics testing lab in a box at the client site is completely managed and operated using our quality management system, SOP’s, methods, and best practices. Our Biologics Testing Solutions offers 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. 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. 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.
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Have you got recent and proven experience of working in GMP laboratories and a focus on QC within GMP regulations? Do you have knowledge and skills in Environmental Monitoring and assays such as Bioburden, Endotoxin and Sterility? Are you experienced in working in accordance to Pharmacopeia regulations? At our customer site in Stevenage, we are excited to be recruiting for a Scientist with proven experience of working within GMP regulations and a strong microbiology skill set to join our existing established team performing method development, qualification, and tech transfer of assays for our customer. Essential Duties and responsibilities: Lead EMPQ for Graded Area. Perform routine room Environmental Monitoring. Conduct Growth Promotion, Colony Counting, Personnel Monitoring, Surface Monitoring. Perform compendial verification and Product Specific Qualification on Bioburden, Endotoxin, Sterility and Rapid Sterility assays. Act as SME for Bioburden, Endotoxin, Sterility, Rapid Sterility testing and associated regulatory requirements. Effective mentoring of staff. Conduct literature searches. Author method SOP’s and qualification/validation/transfer protocols and reports. Provide testing support for QC as needed (execute test methods in a GMP setting). Train and transfer robust assays for QC testing. Contribute to building a culture of continuous learning/improvement and innovation. Maintain current awareness and contribute to current scientific literature and actively apply new concepts and technologies. Able to work independently to execute new test methods. Rigorously analyse and interpret data. Support multiple projects and strong organisational and problem-solving skills. Skills and Experience
MSc or PhD, preferably in a life science or related discipline preferred. Proven experience of working with a GMP environment, microbiology in biology, virology, molecular biology, cell biology, biochemistry, or suitable field preferred. Maintain current awareness and contribute to current scientific literature and actively apply new concepts and technologies. Preferred working experience in viral gene therapy vectors. Previous biologics contract manufacturing organisation or CDMO experience preferred. Microsoft Office experience (Word, Excel, PowerPoint, etc.). Team-player. Able to work independently to execute new test methods. Able to rigorously analyse and interpret data. Able to support multiple projects and strong organisational and problem-solving skills. What We Offer You
A very comprehensive benefits package from day one, including a generous pension contribution, and flexible health benefits. Access to great discounts via our CREDS discount scheme. Global opportunities and strong career progression. The chance to work on several varied projects and liaise globally and nationally with other business areas. To be able make a difference to health and wellbeing of people. To continue your own career growth. Parental leave. Group Life Assurance and Group Income Protection. Remote GP access 24/7. Well being support and initiatives. Cycle to work scheme. About RightSource (Biologics Testing) The biopharmaceutical industry is growing at an unprecedented pace which is simultaneously changing current testing methodologies. To keep up with the demand, we offer a flexible testing platform which can be deployed on-site at the client site to their exact needs. Our biologics testing lab in a box at the client site is completely managed and operated using our quality management system, SOP’s, methods, and best practices. Our Biologics Testing Solutions offers 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. 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. 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.
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