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.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. Job Summary
The Analytical Scientist I/II/III 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 ensuring that the knowledge transfer to QC and supporting groups is efficient and effective. Additionally, this role will be involved in QC method preparation, execution, method qualification / validation, and close out of technology transfer activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Work as part of a cross-functional transfer team to ensure maximum and high-quality output of deliverables for clients
- Assess client QC testing requirements against internal capabilities and experience to identify any testing and / or raw material gaps
- Identify 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
Provide support for investigations and impact assessment
- 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 * Travel may be required for training or analytical transfer activities
- Generate documentation supporting tech transfer and production and provide technical support
EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS
- BS with 2 years/ MS with 1 year/ PhD with 1 year of relevant experience.
- Establishing analytical skills and knowledge of cell culture and GMP.
- Experience in assay development, assessment, implementation, and/or transfer is highly desired.
- Detail oriented with good organizational skills.
- Must possess effective written and oral communication skills.
- Must display a high degree of professionalism and confidentiality.
IMPORTANT: A resume is required to be considered for this position.
- Must demonstrate initiative to remain apprised of relevant industry and regulatory trends.
If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.About Cognate BioServices
Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.
We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.
Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.
For more information, visit www.cognatebioservices.comEqual 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, 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 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.
For more information, please visit www.criver.com.