Supervisor QC BioAssay

Req ID #:  176084
Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118

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

This successful candidate will serve as the bioassays subject matter expert and leader of our bioassay team focused on assays and testing including critical GMP evaluation of new client assays and documentation, oversight and participation in bioassay test method establishment and document conversion at Cognate, training of analysts on new bioassays methods and instrumentation (as applicable), drafting of bioassay qualification/validation protocols and reports and serving as client point-of-contact for bioassay-related inquiries. In addition, the ability to work effectively and autonomously as part of a multi-disciplinary team as well as a strong motivation to achieve company goals is a must for candidates seeking this position. A strong desire not only to learn, but also teach less experienced staff is an additional defining characteristic for this position.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversees QC Bioassay personnel in in-process/final product testing, equipment operation, and training in accordance with cGMPs and Cognate Quality System Conducts and/or schedules training for new employees

• Schedules personnel to support all testing related activities.

• Strong background and experience with cell-based immunological in vitro methods (e.g. MLR, cytotoxicity, HLA-restriction, CTLp, cell proliferation, etc.) and instrumentation.

• Study design, data/statistical analysis (e.g. use of SigmaPlot, JMP and Excel), reporting results in both written and oral format (presentation)

• Familiarity with basic core QC areas including product/material stability, trending, comparability, qualification/validation, compendial methods, etc.

• Knowledge and technical expertise in areas of assay development, optimization and validation leveraging off-the-shelf technologies such as ELISA, flow cytometry, PCR/other molecular biology-based assays)

• Study design, data/statistical analysis, reporting results in both written and oral format (presentation)

• An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control

• Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of all required testing documentation ensuring timely submission relative to product release dates

• Maintains familiarity with QC-relevant cGMP guidances (CFR, USP, EP, ICH, etc.)

• Participates in laboratory, OOS, CAPA or other investigations, as required

 

Job Qualifications

• BS or higher degree in the biological sciences or related field with a minimum of 4 years relevant

laboratory experience or minimum 3 years experience in a cGMP/FDA regulated industry

• Two years of leadership experience preferred

• Familiarity with cGMP as defined in 21CFR210 and 211.

• Ability to work independently and as part of a team

• Detail-oriented with strong written and verbal communication skills

• Ability to problem-solve and troubleshoot as necessary

• Experience with CAR-T is an advantage

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. 


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.  Our main priority is the wellbeing, health, and safety of our people. We require 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.com 


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, 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.


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