Director, Microbiology & Contamination Control

PCI Pharma Services; San Diego (CA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Dental and vision coverage

Flexible spending account

401(k) plan

Job summary

The Associate Director, Microbiology at PCI Pharma Services in San Diego leads the site microbiology organization, directing EM programs, sterile testing, and contamination control within a cGMP framework to meet FDA/EMA expectations. You will partner with Quality, Manufacturing, and Validation to drive continuous improvement and risk mitigation across the site.

The role emphasizes strategic leadership, staff development, and cross-functional collaboration, ensuring robust microbiology systems,

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 relevant Microbiology experience within a cGMP pharmaceutical, biotechnology, CDMO, or related regulated environment.
• Minimum 4 years of progressive leadership or supervisory experience.

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, and investigations.
• Manage Contamination Control Strategy and Committee to identify and mitigate microbiological risks.
• Ensure microbiology systems and practices meet regulatory requirements (FDA, EMA, GMP, USP).
• Lead investigations involving environmental monitoring, sterility, bioburden, endotoxin, and related events.

Skills

Strategic leadership

GMP knowledge

Environmental Monitoring

Microbiology testing

Regulatory readiness

Cross-functional collaboration

Education

Bachelor's degree in Microbiology or Life Sciences

Master's degree preferred

Job description

The Associate Director, Microbiology at PCI Pharma Services in San Diego leads the site microbiology organization, directing EM programs, sterile testing, and contamination control within a cGMP framework to meet FDA/EMA expectations. You will partner with Quality, Manufacturing, and Validation to drive continuous improvement and risk mitigation across the site.

The role emphasizes strategic leadership, staff development, and cross-functional collaboration, ensuring robust microbiology systems,