Director - QC Microbiology
The Director of QC Microbiology is responsible for overseeing all cGMP Microbiology testing including environmental monitoring.
- Oversee the overall Quality Control Microbiology laboratory strategy and operation, with a concentrated focus on facility utilities, environmental classification and control design, program design for Microbiology laboratory equipment, and facility qualification/control.
- Oversee the Aseptic Gowning and Training Program.
- Maintain a robust Environmental Monitoring program that meet US/EU and other applicable regulatory requirements.
- Organize and direct cross functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory.
- Hire staff and manage contract vendors for programs related to the QC Microbiology laboratory.
- Direct laboratory staff, set goals and expectations, and maintain efficient utilization of resources.
- Author and approve documents required for regulatory submissions.
Qualifications - MS in Microbiology discipline and 12+ years of experience in a cGMP microbiology testing laboratory environment, with strong knowledge of regulatory, USP and Eur. PHr guidelines as related to Microbiology issues, aseptic processing, and bio-safety. Ph.D. in life sciences is preferred.
- 8+ years of laboratory management experience.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.