We are seeking a Technician 1 Methods Qualification and Validation for our Biologics Testing Solutions site located in Wayne, PA.
Under direct supervision, perform laboratory activities necessary for analytical or bioanalytical method testing including but not limited to, reagent preparation, laboratory maintenance/monitoring and method performance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Perform tasks using aseptic techniques including working within a biological safety cabinet.
- Participate in the general maintenance of all equipment related to the preparation of assay materials and the analysis of samples, and schedule repairs as required. Perform any laboratory maintenance and/or monitoring as necessary.
- Perform a variety of molecular biology laboratory experiments, tests and procedures following well-defined techniques and guidelines, including isolation and analysis of DNA, RNA, and proteins, PCR, RT-PCR, DNA sequencing and ELISA.
- Make detailed observations and accurately and precisely record data. Summarize data for reports; perform simple graphic analysis of data. Document all activities performed in notebooks and test batch records in accordance with the current Good Manufacturing Practices.
- Bachelor's degree (B.S.) or equivalent in biology or related discipline.
- 0 to 1 year of related experience in a biological laboratory. Knowledge of basic molecular biology techniques or other analytical testing required.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Must possess excellent interpersonal skills to maintain communication across biological functional groups.
- Strong verbal and written communication
- Basic Microsoft Office skills are a plus.
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 17,000 employees within 90 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. And in 2018, revenue increased to $2.62 billion.
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 ~85% of the drugs approved by the FDA in 2019.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet
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 . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.