Sterility Assurance Lead - Biologics
Core
Lead the design, qualification, and operational compliance of sterile manufacturing and contamination control strategies for marketed drug products.
Role type
Senior IC sterility assurance lead (biologics)
Builds
Sterile drug products for the market
Domain
Biopharmaceuticals / GMP manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination control strategy definition, Environmental Monitoring (EM) program governance, microbiological investigation and root cause analysis, aseptic processing expertise, cleanroom design and qualification, regulatory audit support, gowning and sanitization strategy, risk-based decision-making
Preferred skills
None stated
Technologies
None stated
Responsibilities
Own and lead the site Contamination Control Strategy in line with GMP and regulatory expectations; Govern clean utilities and Environmental Monitoring (EM) programmes across classified areas; Analyse EM trends to identify contamination risks and opportunities for improvement; Provide microbiological expertise for investigations, deviations, and product impact assessments; Develop and oversee gowning, cleaning, sanitisation, APS, and air visualisation strategies; Act as the sterility assurance SME for audits, regulatory inspections, and cross-functional initiatives
Seniority
Senior, hands-on IC with supervisory experience