Associate Director, QC Environmental Monitoring (EM) & Sterility

About the role

The Environmental Monitoring & Sterility Operations Lead will be responsible for building the Environmental Monitoring and Sterility Testing programs at our Wilmington site. Initially, this role will function as a hands-on technical expert and individual contributor, personally designing, developing, and executing the EM program infrastructure, sterility testing operations, qualification activities, and foundational documentation. As the site progresses toward full manufacturing operations, the EM Lead will transition into a people leadership role—recruiting, onboarding, and managing a growing team of QC Analysts while shifting focus from hands-on execution to program oversight, coaching, and continuous improvement.

Responsibilities

• Design, develop, and oversee the site Environmental Monitoring program including viable and non-viable monitoring strategies, risk-based sampling plans, alert/action limits, and trending frameworks.
• Establish the sterility testing program in accordance with compendial requirements (USP , EP 2.6.1), including membrane filtration, direct inoculation, and isolator-based operations.
• Author SOPs, sampling plans, method protocols, reports, and training curricula for both programs.
• Evaluate and implement rapid microbiological methods and automation to improve efficiency and reduce time-to-result.
• Lead the design and execution of Environmental Monitoring Performance Qualification (EMPQ) for classified areas.
• Commission and qualify sterility testing suites, isolator systems, and EM instrumentation.
• Support WFI & Utilities commissioning and qualification from a microbiological perspective.
• Conduct compendial method suitability and verification studies.
• Coordinate with Manufacturing, Facilities/Engineering, Quality, and Validation to ensure readiness prior to operational start-up.
• Perform and provide oversight of routine EM sampling (air, surface, personnel monitoring) and sterility testing for batch release, stability, and validation samples.
• Oversee utilities monitoring for WFI, steam, and compressed gases.
• Maintain equipment qualification, calibration, and personnel training/gowning qualification programs.
• Lead investigations for EM excursions and sterility test failures, including root cause analysis, impact assessments, and CAPA implementation.
• Drive continuous improvement in program efficiency, data analytics, and trend visualization.
• Recruit, onboard, and develop a team of EM and Sterility Analysts (~8–12 FTE at full capacity).
• Manage scheduling, performance, development, and succession planning.
• Mentor and coach team members to build a high-performing, inspection-ready culture.
• Represent the EM and sterility testing function in contamination control strategy discussions, site governance forums, and cross-functional meetings.
• Partner with Manufacturing, Engineering, Quality, and Regulatory to align activities with site priorities.

Qualifications / Experience

• Minimum: Bachelor's degree in Microbiology, Biotechnology, Biology, or related life science discipline.
• PREFERRED: Master's degree in a related discipline.
• Minimum of 8 years of experience in pharmaceutical/biotech microbiology with progressive technical responsibility.
• Hands-on expertise in EM program design, execution, and management in classified manufacturing environments.
• Direct experience performing compendial sterility testing (USP , EP 2.6.1), including isolator operations and sterility test failure investigations.
• Proven experience with facility/laboratory start-up activities (EMPQ, equipment qualification, sterility suite commissioning, SOP development for new programs).
• Working knowledge of additional microbiological methods (bioburden, endotoxin, utilities surveillance).
• Experience with laboratory systems and equipment including: LIMS (Laboratory Information Management Systems) for sample management, scheduling, and results reporting Environmental monitoring data systems and trending software (i.e. MODA) Microbiology laboratory instrumentation (e.g., viable/non-viable air samplers, isolators, incubators, autoclaves, endotoxin detection systems, particle counters) Equipment qualification, calibration, preventive maintenance, and change control processes Computerized system validation (CSV) principles as applied to laboratory systems Familiarity with rapid microbiological methods, EM automation, and data analytics tools preferred.
• Prior supervisory experience preferred with demonstrated leadership within a QC operation.

Core Competencies And Skills

• Analytical Thinking
• Antibody Drug Conjugates (ADC)
• Biological Sciences
• Biotechnology
• Change Control Processes
• Counterfeit Detection
• Cross-Functional Teamwork
• Environmental Monitoring
• Immunoassays
• Innovation
• Laboratory Information Management System (LIMS)
• Microbiology
• People Management
• Quality Control (QC)
• Regulatory Compliance
• Sample Management
• Team Leadership