Associate Director, Sterility Assurance
Blackfield Associates are proud to be supporting a leading biopharmaceutical organisation in the search for an experienced Sterility Assurance professional to join their organisation as a Senior Manager / Associate Director.
This position plays a critical role in ensuring the integrity of aseptic manufacturing operations by leading sterility assurance and contamination control activities across GMP environments.
The Role
As the Associate Director of Sterility Assurance, you will:
* Lead microbiological investigations into sterility failures, contamination events, and environmental monitoring (EM) excursions.
* Act as the Subject Matter Expert (SME) for microbiological deviations, providing scientific rationale and ensuring robust root cause analysis and CAPA implementation.
* Collaborate with QA, QC, Manufacturing, Validation, and Engineering to strengthen site-wide contamination control and continuous improvement initiatives.
* Represent sterility assurance during internal and external audits and inspections.
* Support and enhance the site’s contamination control strategy, including microbial risk assessments, trending, and preventive measures.
* Provide technical leadership and mentor the QC Microbiology team in aseptic techniques and regulatory compliance.
* Ensure all activities comply with EU GMP Annex 1, FDA aseptic processing guidance, and other relevant global standards.
About You
We are seeking an accomplished microbiology professional who can demonstrate:
* 10+ years of microbiology experience within GMP-regulated biopharma, ATMP, or sterile manufacturing environments.
* Proven success leading microbiological investigations and contamination control programs.
* Deep expertise in aseptic manufacturing, cleanroom microbiology, and environmental monitoring.
* Strong working knowledge of EU GMP Annex 1, FDA aseptic guidance, and related regulatory expectations.
* Experience acting as SME during MHRA, FDA, or other regulatory inspections.
* Excellent communication and leadership skills, with the ability to influence cross-functional teams.
Preferred qualifications:
* MSc or PhD in Microbiology, Biochemistry, or related discipline.
* Experience with ATMPs, CAR-T manufacturing, or small-scale aseptic operations.
* Knowledge of microbial data trending, risk-based investigation approaches, and contamination control strategies.
* Training in structured root cause analysis tools (e.g., 5 Whys, Fishbone, FTA).