Associate Director, Microbiology

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

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 and implementing contamination control strategies and microbiology improvement programs preferred.

The hiring rate for this position is $150,000 - $170,000 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.