Associate Director, QC Environmental Monitoring (EM) & Sterility

Role responsibilities

The Associate Director will be responsible for designing and implementing the Environmental Monitoring and Sterility Testing programs at the Wilmington site. This includes overseeing routine operations, compliance, and leading a growing team of QC Analysts as the site progresses toward full manufacturing operations.

Requirements

Candidates must have a minimum of 8 years of experience in pharmaceutical/biotech microbiology, with hands-on expertise in EM program design and compendial sterility testing. A bachelor's degree in Microbiology, Biotechnology, Biology, or a related life science discipline is required, with a master's degree preferred.

Key skills

Environmental Monitoring, Sterility Testing, Microbiology, Quality Control, Analytical Thinking, Problem Solving, Collaboration, Leadership Potential, Regulatory Knowledge, Self-Direction, Change Control Processes, Data Analytics, Laboratory Information Management System, Aseptic Manufacturing, Continuous Improvement, Team Leadership

Keywords

Environmental Monitoring, Sterility Testing, Microbiology, Quality Control, Analytical Method Development, Antibody Drug Conjugates, Biologics, cGMP, Data Integrity, Compendial Requirements, Laboratory Systems, Equipment Qualification, Change Control, Rapid Microbiological Methods, Digital Tools, Continuous Improvement