Director Of Quality Control
Company: Charles River Laboratories - Biologics
Posted on: May 16, 2022
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
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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