Quality Control Lead Scientist Microbiology

Job overview

An exciting opportunity has arisen for a proactive and passionate Quality Control Lead Scientist Microbiology to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland. The MMC is in its final design stages, with facility construction planned through to September 2025. This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved

Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

Main duties of the job

Oversee the New Product Introduction (NPI) processes from a Microbiology QC perspective, ensuring successful implementation for products to be manufactured in the Medicines Manufacturing Centre (MMC). This includes:

• Method development Analytical method validation Technology/method transfer Reference standards management Sampling and QC stability testing Ongoing stability studies
• Method development
• Analytical method validation
• Technology/method transfer
• Reference standards management
• Sampling and QC stability testing
• Ongoing stability studies

Supervise QC Microbiology testing for:

• Components and packaging
• Raw materials
• In-process testing
• Finished products
• Environmental monitoring samples

Implement QC Microbiology policies and processes that comply with Good Manufacturing Practice (GMP) and data integrity requirements.

Oversee and manage QC Microbiology documentation, ensuring all records are up to date and comply with regulatory requirements.

Lead training for QC Microbiology staff, ensuring they are proficient in relevant QC methods and regulatory standards.

Prepare and implement QC microbiology documentation such as:

• Worksheets, SOPs, and stability plans QC reports Statistical analysis
• Worksheets, SOPs, and stability plans
• QC reports
• Statistical analysis

Perform assessments for the Pharmaceutical Quality System (PQS), including:

• Out of Specification (OOS) investigations
• Root Cause Analysis (RCA)
• Quality Risk Assessment (QRA)
• QC assessment on Change Control

Perform QC data recording, trending, and statistical analysis for QC microbiology data, and track Key Performance Indicators (KPIs).

Detailed job description and main responsibilities

Support the implementation of stability studies and ongoing stability testing programs, as well as investigational work and validations.

Ensure that analysis on raw materials, packaging components, and finished pharmaceutical products is carried out in line with approved QC worksheets and SOPs.

Oversee the supplier approval process and manage incoming goods checks and testing.

Develop and manage processes for the Microbiology QC Lab and sterility suite, including workload management and resource allocation.

Manage a team of Microbiology Quality Control Scientists, ensuring their development and performance within the laboratory.

Ensure that all QC microbiology equipment is properly qualified and serviced, including managing contractors for outsourced activities.

Demonstrate compassionate and inclusive leadership, contributing to the creation of a collective leadership culture within the Trust by:

• Engaging, enabling, and empowering others Using coaching to promote ownership of learning and quality improvement Facilitating team working and collaboration across teams, departments, and organisational boundaries
• Engaging, enabling, and empowering others
• Using coaching to promote ownership of learning and quality improvement
• Facilitating team working and collaboration across teams, departments, and organisational boundaries