Charles River Laboratories, Inc.
Location
Stevenage, Hertfordshire | United Kingdom
Job description
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.
The Scientist I performs methods development, qualification, and tech transfer of assay for the customer at the customer site in accordance with the contractual statement of work.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
⦁ Develop, optimize, and qualify/validate test methods
⦁ Perform complex assays to compliance in QC
⦁ Conduct literature searches
⦁ Attain status as in-house SME in respective scientific discipline e.g., Analytical, Molecular, Cell based, Stability/regulatory.
⦁ Effective mentoring of junior staff
⦁ Author analytical 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
⦁ Other responsibilities as needed
Contribute to investigations/deviations/CAPAs
⦁ Education: MS or PhD, preferably in a life science or related discipline preferred
⦁ Experience: Proven experience in biology, virology, molecular biology, cell biology, biochemistry, or suitable field preferred
⦁ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
⦁ Certification/Licensure: None.
⦁ Other: Proficiency in molecular biology, cell culture, ELISA, and/or chromatography.
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 organization or CDMO experience preferred. Microsoft Office experience (Word, Excel, PowerPoint, etc.). Team-player. Able to work independently to execute new test method. Able to rigorously analyze and interpret data. Able to support multiple projects and strong organizational and problem-solving skills. Authorized to legally work in the United States without visa sponsorship.
PHYSICAL DEMANDS:
⦁ Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
⦁ Must regularly communicate with employees/customers; must be able to exchange accurate information.
⦁ Must occasionally move about inside the office to access file cabinets, office machinery, etc.
⦁ May occasionally be required to wear protective clothing and equipment.
⦁ Must physically be able to lift up to 40lbs, and work in a laboratory warehouse and office settings
⦁ Must be able, when required to work weekends, nights, or be on-call to support the manufacturing campaigns.
⦁ Must be able to work in laboratory settings and adhere to all safety precautions
WORK ENVIRONMENT:
⦁ General office working conditions and/or laboratory/manufacturing areas.
⦁ The noise level in the work environment ranges from low to moderate.
⦁ May occasionally be required to work in tight or confined spaces.
⦁ May occasionally be exposed to high temperatures and humidity.
Comments:
⦁ May require occasional domestic travel.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
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. RightSource℠ is completely managed and operated using our quality management system, SOP’s, methods, and best practices. It’s as if you shipped your samples to an outsourced lab but walked down the hall instead.
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. 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. 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. 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 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 86% of the drugs approved by the FDA in 2021.
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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