California Licensed Microbiology Manager

Job Summary

To support microbiological quality control activities, the full-time California Licensed Microbiology Manager will manage cGMP-compliance operations for clinical development, oversee microbiological assays, and collaborate with various departments while working onsite in San Carlos, California, or remotely.

Key responsibilities:

• Serve as the technical expert for QC microbiological assays and support the authoring and review of internal SOPs
• Manage quality event management related to microbiology QC and aseptic manufacturing operations
• Collaborate with cross-functional teams to review test methods and provide compliance feedback to stakeholders

Required qualifications:

• Degree in Microbiology, Biology, Biochemistry, or related discipline with relevant experience (7+ years for Ph.D., 9+ years for M.S./M.A., or 11+ years for B.S./B.A.)
• Experience in aseptic manufacturing or microbiology within the Pharma/Biotech industry
• Understanding of GMP release testing and microbial control methods
• Experience in analytical method verification, development, and validation
• Solid understanding of cGMPs, FDA, EU, and ICH regulatory guidelines related to QC operations