Associate Director, Microbiology

pciservices; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

PCI is seeking an Associate Director of Microbiology to provide strategic leadership for the site Microbiology organization, ensuring robust environmental monitoring, testing, and contamination control programs. You will oversee strategy, staffing, and a culture of scientific rigor across cGMP operations.

The role partners with Quality, Manufacturing, Engineering and Validation to meet regulatory expectations and client commitments, driving continuous improvement and technical excellence at the

Qualifications

• 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.
• Minimum 8 years of microbiology experience in a cGMP pharmaceutical/biotech/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.

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, bioburdens, 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.

Skills

Strategic leadership

Microbiology expertise

GMP knowledge

Regulatory affairs

Education

Bachelor's in Microbiology/Life Sciences

Master's preferred

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Associate Director, Microbiology provides strategic and technical leadership for the site Microbiology organization and is responsible for the development, implementation, and ongoing oversight of microbiology programs supporting cGMP manufacturing operations. This role leads the Microbiology team and ensures microbiological testing, environmental monitoring, contamination control, aseptic practices, and associated quality systems meet internal standards and applicable global regulatory requirements.

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