Associate Director, QC Microbiology

Role: Lead and manage all QC Microbiology laboratory activities supporting GMP manufacturing, including environmental monitoring and microbiological testing of materials, intermediates, and finished products. Responsibilities: establish and qualify the new QC Microbiology lab, implement microbiology procedures, support commissioning of new facilities, participate in regulatory inspections, oversee routine testing, investigations, CAPAs, and microbial method verification. Build and mentor a high-performing microbiology team, ensure compliance with FDA/EU regulations, and optimize lab efficiency. Qualifications: minimum 8 years' experience in an FDA-regulated biopharma or biotech environment, with at least 5 years in team management. Expertise in pharmaceutical microbial testing, microbiology equipment, and regulations (USP/EP, cGMP/EU GMP). Bachelor’s in science (microbiology, biotech, pharmaceutical sciences). Strong leadership, analytical, project management, and communication skills. High-value biopharma specifics: microbiology focus supporting biologics manufacturing, environmental monitoring, and contamination control. Work setup: On-site with approximately 10% travel; involved in commissioning and regulatory compliance activities.