Head of Microbiology
Confidential
Head of Microbiology
About the Company
Growing pharmaceutical manufacturer operating a sterile manufacturing facility.
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Company is in need of a Head of Microbiology to take on a pivotal role in leading and developing the microbiology function within a sterile manufacturing facility. The successful candidate will be responsible for overseeing a range of critical activities, including environmental monitoring, sterility assurance programs, and various microbiological testing activities. This role also involves managing contamination control, ensuring regulatory compliance, and leading a team of microbiology professionals. The Head of Microbiology will be expected to partner with cross-functional teams such as manufacturing, QA, QC, validation, and engineering to drive quality and compliance initiatives in this highly regulated environment. Applicants for the Head of Microbiology position at the company should hold a BS in a relevant scientific discipline and have a minimum of 12 years' experience in pharmaceutical microbiology, with a strong background in sterile manufacturing and aseptic processing. Leadership experience within GMP-regulated manufacturing is essential, as is a proven track record of supporting FDA inspections and audit activities. The role requires expertise in environmental monitoring, sterility assurance, and a deep understanding of the associated regulatory requirements. The ideal candidate will be adept at managing microbiology laboratory operations and personnel, and will be instrumental in leading activities such as media fill and aseptic process simulation, as well as supporting contamination investigations and CAPAs.
Functions
- Medical Care/Hospital Administration
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