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Scientist I, Analytical

Charles River Laboratories International Inc (CRL)

Shrewsbury, MA, US, 01545

Scientist I, Analytical Req ID #:  76431 Location: 

Shrewsbury, MA, US, 01545 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. Job Summary We are seeking aScientist 1for ourBiologicssite located inShrewsbury, MA.

The following are responsibilities related to theScientist 1:

• Develop methods, perform, and troubleshoot analytical laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of analytical testing and characterization instrumentation and methodologies.

• Generate high quality method and study protocols for sponsor and internal characterization and sample testing programs.

• Function as contact for the planning and execution of Sponsor interaction related to proposal management, research and method development, and for the design, scheduling, conduct and reporting of studies.

• Assist in oversight of laboratory and mentor technical staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.

• Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices.

• Perform routine testing in techniques such as the following with a high degree of reliability, efficiency and accuracy

o Chromatographic Analyses including Process Related Residuals

o Quantitative Monosaccharide and Sialic Acid Analysis

o ELISA/ Immunoassay Analyses

o Process Residual/Drug Product Excipient Analyses

o N- Terminal Sequencing

o Amino Acid Compositional Analysis/Extinction Coefficient Determination

• Review, interpret, analyze, evaluate, and present data on assigned studies, with minimal assistance from senior scientific staff.

• Perform tabulation and statistical analyses of study data, as required.

• Prepare high quality final reports appropriate for assigned study, including integration of supporting subcontractor(s)’s reports into final reports as required, with minimal assistance

• Ensure that reports, raw data specimens, and supporting study documentation are transferred to the archives at the close of each study.

• Provide scientific and technical guidance within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.

• Manage or assist with improvement projects (e.g. redesign of SOP’s, research procedures or report formats).

• Attend scientific meetings, conferences and training courses to enhance job and professional skills.

• Perform other related duties as assigned.

The following are minimum qualifications related to theScientist 1position:

• Bachelor’s degree (B.A. /B.S.) or equivalent in Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.

• Minimum five years of relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.

• 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 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

 

Nearest Major Market: Worcester

Job Segment: Chemistry, Analytics, Scientific, Biotech, Scientist, Science, Engineering, Management

Job posted: 2020-09-28

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