Associate Director, QC Environmental Monitoring (EM) & Sterility

Job Summary We are seeking an Environmental Monitoring & Sterility Operations Lead to build and lead EM and sterility testing programs at our Wilmington Biotech Campus. The role will start as a hands‑on technical expert and evolve into a people‑leadership position as the site approaches full manufacturing operations. Key Accountabilities EM & Sterility Operations Design, Development & Oversight – Design and implement site EM program, develop sampling plans, SOPs, rapid microbiological methods and automation to improve efficiency. Facility & Laboratory Start‑Up – Lead EMPQ, commission and qualify sterility testing suites, support WFI & utilities commissioning, and coordinate with plant functions for readiness. Routine Operations & Compliance – Perform routine EM sampling and sterility testing, oversee utilities, maintain equipment qualification and training, investigate excursions and implement CAPA. Leadership & Collaboration – Recruit and develop a team of 8–12 EM and Sterility Analysts, manage performance and succession planning, and partner with cross‑functional teams on contamination control strategy. Qualifications / Experience Education – Bachelor’s degree in Microbiology, Biotechnology, Biology or related life science discipline (Master’s preferred). Experience – 8+ years in pharmaceutical/biotech microbiology with progressive technical responsibility, hands‑on EM program design and compendial sterility testing, facility/laboratory start‑up, and microbiological method expertise. Proficiency with LIMS, EM data systems (e.g., MODA), microbiology instrumentation, equipment qualification, CSV principles, and rapid microbiological methods. Prior supervisory experience preferred with demonstrated mentorship or informal leadership. Core Competencies and Skills Technical Expertise – Deep knowledge of pharmaceutical EM, sterility testing, contamination control and aseptic manufacturing. 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 for EM excursions and sterility test failures. Adaptability – Comfortable with evolving responsibilities, shifting from hands‑on execution to strategic oversight. Collaboration – Ability to work effectively across Manufacturing, Engineering, Quality, and Regulatory functions. Additional Information Location: Wilmington, Delaware (on‑site) Physical Requirements: Ability to gown into classified environments and perform sampling/testing while wearing appropriate PPE, including respirators. Travel: ~10% Benefits Competitive salary ($129,000 – $203,100) Annual bonus and long‑term incentive (if applicable) Medical, dental, vision and insurance benefits for employee and family 401(k) retirement plan Paid holidays, vacation and compassionate/sick days Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr MSD Malaysia