Associate Director, Microbiology

The Associate Director serves as a key Microbiology subject matter expert and strategic partner to Quality, Manufacturing, Engineering, Validation, and other site functions. The role is responsible for developing organizational capability, driving continuous improvement, supporting regulatory and client commitments, and maintaining a robust contamination control strategy across the site.

Responsibilities

• Provide strategic leadership and direction for the site Microbiology organization, including staffing, talent development, performance management, and succession planning.
• Establish and execute short- and long-term Microbiology objectives aligned with site and business priorities.
• Oversee microbiology programs including Environmental Monitoring (EM), microbial testing, contamination control, aseptic practices, utilities monitoring, and microbiological investigations.
• Provide leadership for the site Contamination Control Strategy (CCS) and Contamination Control Committee, ensuring effective identification, assessment, and mitigation of microbiological risks.
• Partner with Manufacturing, Quality, Engineering, Validation, and other functions to ensure robust contamination control and aseptic processing practices.
• Ensure microbiology systems, procedures, and practices remain aligned with cGMP, FDA, EMA, USP, and other applicable regulatory and industry requirements.
• Oversee development, implementation, and maintenance of microbiological methods, procedures, specifications, and testing programs.
• Provide technical oversight and critical review of microbiology data, trends, investigations, deviations, CAPAs, technical reports, and related quality records.
• Identify microbiological trends and emerging risks and lead appropriate corrective and preventive actions.
• Provide technical leadership for investigations involving environmental monitoring, microbial excursions, sterility, bioburden, endotoxin, media fills, and other microbiological events.
• Support validation and qualification activities for facilities, equipment, utilities, and microbiology processes.
• Represent Microbiology as a subject matter expert during internal and external audits, regulatory inspections, client audits, and technical discussions.
• Partner with clients on microbiology-related process development, technology transfer, testing, monitoring, investigations, and quality requirements.
• Establish and maintain a culture of scientific rigor, compliance, accountability, continuous improvement, and operational excellence.
• Develop and maintain appropriate departmental staffing, training, competency, budget, and capital plans.
• Ensure personnel are appropriately trained and qualified in microbiology testing, cGMP requirements, SOPs, safety, and aseptic practices.
• Build strong cross-functional partnerships and effectively communicate microbiological risks, trends, and recommendations to site leadership.
• Identify opportunities to improve microbiology processes, reduce operational variability, increase efficiency, and strengthen the site's overall contamination control program.
• Maintain transparent and effective communication with employees, site leadership, clients, and cross-functional stakeholders.
• Promote PCI's values and culture while developing a high-performing, engaged, and accountable Microbiology organization.

Requirements

Education

• Bachelor's degree in Microbiology, Biology, Life Sciences, or a related scientific discipline required.
• Master's degree in Microbiology, Life Sciences, or related discipline preferred.

Experience

• Minimum 8 years of relevant Microbiology experience within a cGMP pharmaceutical, biotechnology, CDMO, or related regulated environment.
• Minimum 4 years of progressive leadership or supervisory experience.
• Demonstrated experience leading microbiology programs supporting sterile or aseptic manufacturing operations.
• Strong working knowledge of GMP, USP, Environmental Monitoring, contamination control, aseptic processing, microbial testing, and microbiological investigations.
• Experience supporting regulatory inspections, client audits, and remediation activities preferred.
• Experience developing and implementing contamination control strategies and microbiology improvement programs preferred.