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Director Of Quality Control

Company: Charles River Laboratories - Biologics
Location: Memphis
Posted on: May 16, 2022

Job Description:

POSITION SUMMARY
Reporting to the CVP Global Biologics, the Director of Quality Control - Analytical 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 and is anticipating manufacturing commercial products. The position will also be responsible for Analytical functions to support the manufacturing and release of these products within the Memphis Laboratories. The incumbent is responsible for ensuring that these activities are timely, efficient and productive while adhering to client's requirements and operational and quality parameters.

ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for ensuring that project objectives are met & continuous improvement of the Analytical Laboratories.
- 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 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 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.
- Responsible for the development and delivery of training materials to ensure that the operational, scientific, and analytical training of all QC employees is conducted as the need arises to ensure that the group is completely and accurately trained in a timely manner for all QC activities.
- Responsible for liaison with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units.
- The incumbent serves as an interview panel member for open positions at Cognate.
- Provide support in resolving issues to meet project goals and deliverables.

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

- 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 / Laboratory / Medical Device/Pharmaceutical /Manufacturing environment required.

Keywords: Charles River Laboratories - Biologics, Memphis , Director Of Quality Control, Executive , Memphis, Tennessee

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