Associate Director, QC Environmental Monitoring (EM) & Sterility

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 <71>, 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