- 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
- 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.
- 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
- 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.
- May require occasional domestic travel.
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.
For more information, please visit www.criver.com.