Role Summary
Autolus is seeking an experienced sterility assurance professional to take on a senior technical role within the Microbiology function as Associate Director, Sterility Assurance. This role is accountable for leading microbiological investigations related to sterility failures, environmental monitoring (EM) excursions, and contamination events across our GMP operations.
As Associate Director, Sterility Assurance, you will act as the subject matter expert (SME) for microbiological deviations, ensuring rigorous root cause analysis, strong scientific rationale, and effective CAPAs. You will work closely with cross-functional teams including QA, QC Microbiology, Manufacturing, Validation, and Engineering to resolve complex issues and strengthen the site's contamination control strategy.
This is a role for an experienced microbiologist with deep technical expertise, strong investigational skills, and the ability to influence across functions. It is a leadership position with direct line management.
Key Responsibilities
· Lead site investigations involving sterility failures, contamination events, and EM excursions, ensuring scientific integrity and timely resolution
· Serve as the SME for sterility assurance within the QC Microbiology team, representing the function during audits and inspections
· Identify true root causes and drive implementation of sustainable, risk-based CAPAs
· Support and enhance the site’s contamination control strategy, including microbial risk assessments and trending
· Collaborate with QA, QC, Manufacturing, Validation, and Engineering to ensure alignment on microbiological issues and preventive actions
· Promote consistent use of structured root cause analysis tools and data-driven decision-making in microbiology investigations
· Ensure all sterility assurance activities comply with EU GMP Annex 1, FDA aseptic guidance, and other relevant regulatory expectations
· Provide technical leadership within the QC Microbiology function to embed best practices and support continuous improvement.
· Support sterility assurance assessments for new systems including process, equipment and facility
· Contribute to the existing collaborative attitude in a fast paced, high impacting environment
Demonstrated skills and competencies
Essential (E)
Preferred (P)
· MSc or PhD in Microbiology, Biochemistry, or a related life science discipline (P)
· Minimum 10 years of microbiology experience in a GMP-regulated biopharma, ATMP, or sterile manufacturing environment (E)
· Strong track record in leading microbiological investigations, including sterility failures and contamination events (E)
· Deep expertise in aseptic manufacturing, cleanroom microbiology, EM programs, and contamination control (E)
· In-depth knowledge of EU GMP Annex 1, FDA aseptic guidance, and other relevant global regulations (E)
· Experience acting as SME during MHRA, FDA, or other regulatory inspections (E)
· Excellent written and verbal communication skills, with the ability to clearly present complex technical information (E)
· Demonstrated ability to work cross-functionally and influence without direct authority (E)
· Experience with ATMPs, CAR-T manufacturing, or small-scale aseptic operations (P)
· Skilled in microbial data trending, EM analytics, and risk-based investigation approaches (P)
· Formal training in structured RCA tools (e.g. 5 Whys, Fishbone, Fault Tree Analysis) (P)
· Understanding of contamination risks associated with facility and equipment design (P)
· Experience contributing to or maintaining a Contamination Control Strategy in a GMP environment (P)