Director Quality Control

Director Quality Control Req ID #:  207271 Location: 

Memphis, TN, US, 38118 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. Job Summary  

The Director of Quality Control will be responsible for management and oversight of a large QC Analytical staff and multiple Laboratories in a Cell and Gene Therapy contract manufacturing facility producing Phase 1, 2 and 3 clinical cell and gene therapy products that is anticipating manufacturing commercial products.

ESSENTIAL DUTIES AND RESPONSIBILITIES Responsible for Analytical functions to support the manufacturing and release of products within the Memphis Laboratories. The incumbent will ensure that these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters. Ensure project objectives are met & continuous improvement of the Analytical Laboratories. Manage the development and delivery of training materials to ensure that the operation, scientific, and analytical training of all QC employees is conducted as the need arises to ensure the group is completely and accurately trained in a timely manner for all QC activities. Will liaise with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units. Serve as an interview panel member for open positions at Charles River. Provide support in resolving issues to meet project goals and deliverables. Job Qualifications

  An appropriate area of specialization and 8 years of appropriate experience; and/or training; or equivalent combination of education and experience. Experience working in a GMP / Cell & Gene Therapy environment required. Strong scientific background and experience with cellular therapies across a broad range of cell types and disease treatments (adult-derived cells, stem cells, immune cells. allogeneic, autologous, etc.) Experience preferred with gene-modification modalities, cell-based gene therapies, and the types of QC testing required for such products (RCV, QPERT, transduction efficiency via qPCR, etc.). Familiarity preferred with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH). Understanding of analytical method qualification and validation per USP, EP and ICH guidelines.

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 over 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, 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.

Nearest Major Market: Memphis

Job Segment: Pharmaceutical, Supply Chain, Laboratory, Quality Assurance, Biotech, Science, Operations, Technology