Analytical Scientist II
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Analytical Scientist II Req ID #: 206791 Location:
Memphis, TN, US, 38118 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.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
We are seeking an Analytical Scientist II for our Cell Therapy Manufacturing Facility located Memphis, TN.
The Analytical Scientist II will provide analytical technical support for incoming technology transfers of client test methods for advanced cell therapies. This role will participate in the analytical transfer process and will ensure that the knowledge transfer to QC and supporting groups is efficient and effective. This role will lead in the analytical transfer process by ensuring that the knowledge transfer to QC and supporting groups is efficient and effective. This role will lead in QC method preparation, execution, method qualification / validation, and close out of technology transfer activities.
The following are responsibilities related to the Analytical Scientist II:
• Lead assay tech transfers, as part of a cross-functional transfer team, to ensure maximum and high-quality output of deliverables for clients.
• Lead the assessment of client QC testing requirements against internal capabilities and experience to identify any testing and / or raw material gaps.
• Lead the identification of any gap or technical mitigations to high-risk items and present to leadership for endorsement.
• Provide laboratory support and troubleshooting for QC and supporting groups to ensure transfer of testing knowledge was effective.
• Monitor and analyze transferred test method performance (QC) and troubleshoot technical difficulties as needed.
• Ensures tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
• Assist in expanding analytical knowledge, controls for analytical transfer consistency, and continuous improvement.
• Receives occasional guidance from supervisor regarding planning activities, assigned deliverables, and timelines.
• Leads the generation of documentation supporting tech transfer and production and provide technical support.
• Travel may be required for training or analytical transfer activities. Job Qualifications
The following are minimum qualifications related to the Analytical Scientist II position:
• BS with 3+ years/ MS with 2 year/ PhD with 1+ year of relevant experience.
• Experience with cGMP. Experience in cGMP assay development (design and characterization), assessment, implementation (including troubleshooting), and/or transfer is highly desired.
• Established cGMP analytical skills and knowledge of cell culture and cell processing and testing.
• Established analytical assay troubleshooting in a cGMP environment.
• Detail oriented with good organizational skills.
• Effective written and oral communication skills.
• High degree of professionalism and confidentiality.
• Take the initiative to remain apprised of relevant industry and regulatory trends.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 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.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
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 [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
Nearest Major Market: Memphis
Job Segment: Pharmaceutical, Research Scientist, Technical Support, Laboratory, Cell Biology, Science, Technology
Similar CRA jobs
Scientist, Antibody Engineering
Pre-Analytical Service Coordinator
Associate Scientist, Discovery - Future Opportunities
Scientist - Project Scientist - Bioanalytical
Pre analytical Services Associate (Tuesday to Friday 9am-5pm and Saturday 8am - 4 pm)
Analyst I - Analytical Chemistry
Sr Scientist - Serology
Scientist - Drug Product Development
Scientist- 3rd shift
Scientist 1, Immunoassay
Scientist - Physical Chemistry
Research Scientist -LC/MS
Medical Statistician / Real-World Data Scientist
Global Anatomic Pathology Scientist
Vaccines Scientist I
In-Vivo Imaging Scientist
Assoicate Scientist - Cell Culture (6 month term)
Scientist 1 Environmental Flex Collector-3531
Research Scientist 1 (Bioanalytical Chemistry) 1