BioTalent are partnered with a key client who are looking for an experienced microbiologist to join as Associate Director, Sterility Assurance. This is a senior technical role within the Microbiology function, responsible for leading investigations into sterility failures, contamination events, and environmental monitoring excursions across GMP operations.

You will act as the site’s subject matter expert for microbiological deviations, ensuring high-quality scientific rationale, rigorous root cause analysis, and implementation of effective CAPAs. The role involves close partnership with QA, QC Microbiology, Manufacturing, Validation, and Engineering, and plays a key part in strengthening the contamination control strategy.

This is a leadership role with line management responsibility and significant cross-functional influence.

Key Responsibilities

• Lead microbiological investigations, including sterility failures, contamination events, and EM excursions

• Serve as SME for sterility assurance during audits and regulatory inspections

• Identify true root causes and drive sustainable, risk-based CAPAs

• Support and improve the site’s contamination control strategy, including risk assessments and data trending

• Collaborate closely with QA, QC, Manufacturing, Validation, and Engineering teams

• Promote structured RCA tools and data-driven decision-making across investigations

• Ensure alignment with EU GMP Annex 1, FDA aseptic guidance, and other global regulatory expectations

• Provide technical leadership within the QC Microbiology group

• Support sterility assurance reviews for new equipment, processes, and facilities

• Contribute to a collaborative, fast-moving environment with high scientific standards

Requirements:

• 10+ years of microbiology experience in GMP biopharma, ATMP, or sterile manufacturing

• Proven track record leading microbiological or sterility investigations

• Deep knowledge of aseptic manufacturing, cleanroom microbiology, EM programmes, and contamination control

• Strong understanding of EU GMP Annex 1 and FDA aseptic guidance

• Experience acting as SME during MHRA, FDA, or similar inspections

• Excellent communication skills and ability to influence across teams

Preferred:

• MSc or PhD in Microbiology, Biochemistry, or a related field

• Experience with ATMPs, CAR-T, or small-scale aseptic operations

• Skilled in microbial trending, EM analytics, and risk-based approaches

• Training in structured RCA tools such as 5 Whys, Fishbone, or FTA

• Understanding of contamination risks linked to facility and equipment design

• Experience contributing to a Contamination Control Strategy

Reach out for more information.