Microbiology Program Director – Strategy & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Health insurance (including dental and

Vision coverage

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services is seeking an Associate Director of Microbiology to provide strategic leadership for the site Microbiology organization, ensuring testing, environmental monitoring, contamination control, aseptic practices, and quality systems meet global regulatory standards.

This role partners with Quality, Manufacturing, Engineering, and Validation to drive continuous improvement and robust contamination control.

Qualifications

• Bachelor’s degree in Microbiology, Life Sciences, or related field.
• Master’s degree preferred in Microbiology or Life Sciences.

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, microbial testing, contamination control, aseptic practices, and related quality systems.
• Lead Contamination Control Strategy and Committee to identify, assess, and mitigate 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 meet cGMP, FDA, EMA, USP, and other regulatory requirements.
• Develop and maintain microbiological methods, procedures, specifications, and testing programs.
• Provide oversight and review of microbiology data, trends, investigations, deviations, CAPAs, and technical reports.
• Identify microbiological trends and risks and drive corrective/preventive actions.
• Lead investigations involving environmental monitoring, microbial excursions, sterility, bioburden, endotoxin, media fills, and related events.
• Support validation/qualification for facilities, equipment, utilities, and microbiology processes.
• Represent Microbiology during audits, inspections, client audits, and technical discussions.
• Collaborate with clients on microbiology-related process development and testing requirements.
• Foster a culture of scientific rigor, compliance, accountability, continuous improvement, and operational excellence.
• Develop staffing, training, competency, budget, and capital plans.

Skills

Strategic leadership

Microbiology

Regulatory compliance

Environmental Monitoring

Aseptic processing

Quality systems

Education

Bachelor's degree in Microbiology or Life Sciences

Master's degree in Microbiology or Life Sciences

Job description

PCI Pharma Services is seeking an Associate Director of Microbiology to provide strategic leadership for the site Microbiology organization, ensuring testing, environmental monitoring, contamination control, aseptic practices, and quality systems meet global regulatory standards.

This role partners with Quality, Manufacturing, Engineering, and Validation to drive continuous improvement and robust contamination control.