The Quality Control Senior Director is responsible for the execution of cGMP MFG Facility Environmental Monitoring, cleanroom gowning certification program, WFI/ Purified Water, and sanitary gas systems (C02, N2, O2, CA) testing. The position will be responsible for implementation and continuous improvement of all processes/ systems in support of the Microbiology, Environmental Monitoring and Aseptic Gowning Programs for the Manufacturing Plant. The position will support GMP testing of the Company’s products including recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and gene modified hematopoietic stem cells. This position will also support management of the Company’s designated Contract Testing Organizations (CTOs).

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1. Manages and provides expert knowledge in the contract QC Micro Laboratory support of the Environmental Monitoring support of the EMPQ preparation, execution, and closeout.

2. Ensure the contract QC Lab conform to company standards and to regulatory requirements.

3. Verify the contract EM sampling team is trained and executes the EM testing per SOP.

4. Oversees environmental action level reports and investigations and trend reports and tracking the effectiveness of preventive actions.

5. Provide support in the development of the QC Micro Lab method qualification, protocol preparation, qualification execution, and report approval.

6. Manages EMPQ deviation and out-of-specification reports and investigations and tracking the effectiveness of preventive action.

7. Provide support in the new QC Lab SOP development and layout

8. Oversees contract lab testing activities.

9. Coordinates testing including validation and qualification, and the dissemination of the results of those activities to the relevant customers.

10. Responsible for meeting deadlines under a tight timeline and changing priorities.

11. Support site external supplier audits as SME.

12. Facilitate of QC project meetings and functional sub-team by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines

13. Work with QC management and project team lead to identify and mitigate risks to meeting QC milestones and goals.

14. Ensures assigned projects are conducted in compliance with applicable Tech Ops procedures Write and revise standard operating procedures as needed.

15. Oversee QC activities at CTOs, including the review of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs Review of SOPs, records/forms and protocols for in-house QC testing and overall QC operations.

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EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Bachelor's degree or advanced degree in Microbiology or related discipline.

• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.

• 8+ years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility with strong knowledge of regulatory, USP and Eur. Phr guidelines as related to Microbiology issues, environmental monitoring, aseptic processing, and biosafety.

• 5+ years’ experience managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.

• Strong data integrity knowledge and practices.

• Strong knowledge of contamination control, disinfection, cleanroom design and operation, and aseptic techniques.

• Experience starting up lab facilities supporting clinical and/or commercial manufacturing. Proficient in MS Word, Excel, Power Point and other applications.

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

• Knowledge of Good Manufacturing Practices and Good Laboratory Practices.

• Solid communication and presentation skills required.

• Experience of managing CMO/CTO relationships and projects

• Sound understanding and demonstrated application of statistical methods/tools

• Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills

• Ability to operate in a fast-paced, multi-disciplinary industrial environment.