Senior QC Microbiologist/ Manager QC Microbiology in Emeryville, California at ZYLIDAC BIO LLC

• Perform and review microbiological testing, including bioburden, endotoxin (LAL), sterility testing, and microbial identification
• Oversee and trend environmental monitoring (EM) data in classified cleanroom areas (ISO 5–8 / Grade A–D) and utilities (WFI, Compressed gases)
• Oversee Process monitoring and Media fills
• Lead investigations for OOS, OOT, EM excursions, and contamination events
• Author and review deviations, CAPAs, SOPs, and technical reports
• Support method validation, verification, and transfer activities
• Support cleaning validation/verification and disinfectant efficacy studies
• Ensure compliance with GMP, USP, and regulatory requirements (FDA, EMA, ICH)
• Act as SME for microbiology during audits and inspections
• Train and mentor junior staff and support cross-functional teams
• Contribute to contamination control strategy (CCS) and continuous improvement initiatives

• Bachelor’s or Master’s degree in Microbiology, Biology, or related field
• 10+ years of QC microbiology experience in a biologics, pharmaceutical, or aseptic manufacturing environment

Strong knowledge of:

• GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1)
• USP microbiology chapters (e.g., [61], [62], [71], [85], [1116])
• Environmental monitoring in cleanrooms