Sterility Assurance Associate Director

Associate Director, Sterility Assurance

Location: Stevenage, UK - hybrid

Sector:
Biopharmaceuticals, GMP Manufacturing

Type:
Full-time, Permanent

The Company

A clinical-stage biopharmaceutical organisation is developing next-generation programmed T-cell therapies for cancer. Their approach combines advanced cell engineering, modular technology platforms, and a strong scientific foundation to create precisely targeted and highly active therapies. Their pipeline includes candidates for both haematological cancers and solid tumours.

The team works in a flexible, diverse, and collaborative environment that encourages creativity, ownership, and teamwork. Employees benefit from competitive salaries, performance bonuses, private medical insurance, pension, life assurance, and access to a share scheme.

The Opportunity

The company is 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

About You

Essential:

• 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

Inclusion Matters

The company is committed to equality and inclusion. They value different backgrounds, perspectives, and experiences, and work hard to create an environment where everyone feels respected and able to contribute.