For 70 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.
We are seeking an experienced Research Associate I – Analytical for our Biologics group located in Shrewsbury, MA.
In this position, the Research Associate I will work independently on client-specific experimental design, moderately complex professional tasks, report development, quality control, and research. Key responsibilities of this role include:
· Independently perform laboratory activities including but not limited to reagent preparation, laboratory maintenance/monitoring of equipment, routine testing of client samples, and the generation of routine cGMP and R&D reports
· Perform a variety of analytical laboratory experiments, tests and procedures including:
o Routine compendial (USP and Non-USP) testing offerings
o Demonstrated proficiency in a minimum of 2 Advanced Routine Testing offerings which include but are not limited to:
o § Biologics Chromatography Analyses
§ Process Related Residuals Chromatographic Analyses
§ Quantitative Monosaccharide and Sialic Acid Analysis
§ ELISA/ Immunoassay Analyses
§ Drug Product Excipient Analyses
§ N- Terminal Sequencing
§ Amino Acid Compositional Analysis/Extinction Coefficient Determination
· Excellent pipetting skills as listed below:
o Single Pipetting
o Multichannel pipetting
o Repeat Pipetting
o Reverse Pipetting
· Make detailed observations and accurately and precisely record data.
· Assist in the monitoring of key project events.
· Troubleshoot unexpected/invalid results, prioritize workload and solve moderately complex problems.
· Provide peer review and technical review of documents, reports and data.
· For both cGMP and R&D grade routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines.
· Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
· Perform assay and equipment troubleshooting with minimal guidance from senior members of the group.
· Independently compose high quality documentation including deviation reports and change control documentation with no/minimal guidance.
· Participate in client/sponsor relationships (e.g. technology transfer, conference calls and sharing of technical information).
· Create, review and edit SOPs, protocols and other data forms and testing documentation.
· Perform all other related duties as required
The following are minimum requirements related to the Research Associate I – Analytical position.
· Education: Bachelor’s degree (B.S.) or equivalent in biochemistry, chemistry or related discipline.
· Experience: Minimum 3 of years related industry experience in an analytical laboratory in the Pharmaceutical, Biotech or contract research laboratory (CRO) environment.
· An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
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 14,000 employees within 80 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 by 22% to $2.27 billion from $1.86 billion in 2017.
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 2018.
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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications