Quality Control Lead Scientist Microbiology

Northumbria Healthcare NHS Foundation Trust; Seaton; On-site; GBP 40,000 - 60,000; Full time

Job summary

An exciting opportunity for a Quality Control Lead Scientist Microbiology to join a pioneering NHS pharmaceutical production facility in Seaton Delaval. The role involves overseeing microbiology QC processes, managing a team, and ensuring compliance with GMP standards. Ideal candidates will have a degree in a relevant scientific discipline and experience in pharmaceutical microbiology. This is a chance to contribute to high-quality medicine production in a supportive environment focused on innovation and patient care.

Qualifications

• Knowledge of EU GMP, including Annex 1.
• Experience in pharmaceutical microbiology within a GMP environment.

Responsibilities

• Oversee NPI processes from a Microbiology QC perspective.
• Manage and develop a team of Microbiology QC Scientists.
• Ensure proper qualification and servicing of microbiology equipment.

Skills

Analytical

Technical

Leadership

Education

Degree in a relevant scientific discipline

Job description

Job summary

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 MMC are employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service transfer to another owner, employees with start dates prior to the transfer will be protected under TUPE regulations, transferring on the same terms and conditions, with employment continuity preserved.

Main duties of the job

• Oversee NPI processes from a Microbiology QC perspective, including method development, validation, transfer, standards management, sampling, and stability testing.
• Supervise QC Microbiology testing for components, raw materials, in-process, finished products, and environmental samples.
• Implement QC Microbiology policies complying with GMP and data integrity standards.
• Manage documentation, training, and prepare QC microbiology documentation such as SOPs, reports, and statistical analyses.
• Perform assessments for PQS, including OOS investigations, RCA, QRA, and change control evaluations.
• Record, trend, and analyze QC microbiology data, tracking KPIs.

About us

The MMC is a purpose-built NHS pharmaceutical facility in Seaton Delaval, established to meet regional needs for high-quality medicines, especially oncology and high-risk therapies. Funded by NHS England with £30 million, it supports a sustainable supply chain, operates under a Manufacturer’s Specials Licence, and aims for WDA(H) compliance, ensuring MHRA, GMP, and GDP adherence. Our culture emphasizes quality, safety, staff wellbeing, and continuous improvement, offering staff a unique opportunity to shape a modern NHS manufacturing environment.

Job description

Job responsibilities

• Support stability studies, validations, and investigational work.
• Ensure analysis of raw materials, packaging, and finished products aligns with approved SOPs.
• Oversee supplier approval, incoming goods checks, and testing.
• Develop processes for the Microbiology QC Lab and sterility suite, managing workload and resources.
• Manage and develop a team of Microbiology QC Scientists.
• Ensure proper qualification and servicing of microbiology equipment, managing contractors for outsourced activities.
• Demonstrate compassionate leadership, fostering a culture of collaboration, ownership, and continuous learning, including coaching and team facilitation.

Person Specification

Qualifications

• Degree in a relevant scientific discipline or equivalent experience.
• Eligibility for registration with GPhC, HCPC, RSC, RSB, or RPS.

Desirable qualifications

• Professional registration and postgraduate qualifications in pharmaceutical microbiology, pharmaceutical science, or GMP.

Experience

• Knowledge of EU GMP, including Annex 1.
• Experience in pharmaceutical microbiology within a GMP environment.
• Strong technical, analytical, and risk assessment skills.
• Experience with microbiology testing techniques per BP requirements, including qualification of methods.
• Knowledge of laboratory instrument qualification, trending, and statistical data analysis.
• Experience implementing laboratory safety protocols (e.g., COSHH).

Additional desirable experience

• Experience with NPI from a QC perspective.
• Familiarity with Pharmaceutical Quality Systems, OOS investigations, root cause analysis, change control, and document management.
• Experience with sterile medicines QC micro testing aligned with pharmacopeial standards.
• Knowledge of technical developments in pharmaceutical manufacturing.
• Management experience, including laboratory oversight, coaching, and quality improvement practices.

Other requirements

This role is subject to DBS checks. Applicants requiring Skilled Worker sponsorship are welcome; further details are available on our website. Note that UK entry clearance requirements include presenting a criminal record certificate from each country of residence over 12 months in the past 10 years, including adult dependants.