Associate Director, QC Environmental Monitoring (EM) & Sterility

Job description

Job Description At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology. This site will establish our company’s internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to it’s global network. Wilmington Biotech Campus – Quality Control Laboratory The QC Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics including deep pipeline of Antibody Drug Conjugates. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. Reporting to Microbiology Operations Lead, the Environmental Monitoring & Sterility Operations Lead will be a foundational hire 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. This is an ideal opportunity for a self-directed EM and sterility testing professional who thrives in building new programs independently and is ready to grow into team leadership as the organization scales. Key Accountabilities: EM & Sterility Operations Design, Development & Oversight In collaboration with site Quality, design and implement the site EM 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. Facility & Laboratory Start-Up In collaboration with site Quality, 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. Routine Operations & Compliance 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. Ensure compliance with cGMP, biosafety, data integrity, and corporate policies across all activities. 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. Leadership & Collaboration As the site scales toward routine operations, 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 Education Minimum: Bachelor's degree in Microbiology, Biotechnology, Biology, or related life science discipline. Preferred: Master's degree in a related discipline. Experience 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 Technical Expertise: Deep knowledge of pharmaceutical EM, sterility testing, contamination control, and aseptic manufacturing support Self-Direction: Ability to work autonomously and build programs with minimal oversight during start-up Leadership Potential: Readiness to grow into people management with evidence of mentoring or informal leadership Regulatory Knowledge: Strong understanding of USP , USP , EU Annex 1, FDA guidance, and PDA Problem Solving: Excellent investigation and root cause analysis skills, particularly for EM excursions and sterility test failures Adaptability: Comfort with evolving responsibilities, shifting from hands-on execution to strategic oversight as the site matures Collaboration: Ability to work effectively across Manufacturing, Engineering, Quality, and Regulatory functions Additional Info: Location (on-site): Wilmington, Delaware Physical Requirements: Ability to gown into classified environments and perform sampling/testing while wearing appropriate PPE, including respirators for high potent compound areas. Travel: ~10% Required Skills: