Director, QC Microbiology

Posted 2 months 12 days ago by Cognate BioServices

Permanent
Not Specified
Laboratory Jobs
Tennessee, Memphis, United States, 37501
Job Description

The Director of Quality Control- Microbiology will be responsible for management and oversight of the QC Microbiology Laboratory in a Cell and Gene Therapy contract manufacturing facility. The facility currently supports multiple clients 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 Microbiological functions to support the manufacturing and release of these products: as well as new, method development and qualification.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Management and Improvement of current Quality Control- Micro procedures including methods, workflows and continuous improvement.

2. Evaluation of the laboratory and its capabilities to ensure that new methodologies can be implemented.

3. Build solid cross-functional relationships with relevant internal and external departments necessary to ensure a smooth transition into Cognate's Quality System.

4. Will support the implantation of a Laboratory Information management system (LIMS) to be utilized for Quality Control - Micro sample management.

5. Maintain knowledgebase on policies and procedures concerning Cognate's Quality Systems and operational philosophies.

6. Development of Quality Control- Micro staff members at varying levels of experience.

7. Experience with performing Environmental Alert/Actions investigations.

8. Other duties, task or project as assigned.


EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

1. Demonstrated knowledge of current GXP regulatory interpretations of Microbiological Quality

Control and Assay development requirements, current industry best practice in the area of

biologics or cell and gene therapy manufacturing preferred.

2. Previous experience in the development and use of Electronic laboratory Information Systems

and Analytical Metric Analysis to drive continuous improvements.

3. Ability to multi‐task effectively.

4. Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS

software.

5. Strong analytical, problem‐solving, and project management skills.

6. Good leadership/interpersonal/communication/influencing /negotiation skills.

7. BS degree in science or engineering.

8. 7 years of experience in a regulated commercial manufacturing environment supporting a

Quality Control function.

9. Experience supporting customer audits or Regulatory inspections.

10. Management of a department or of varying levels of experience in a quality control laboratory

setting.

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