QC Microbiology Shift Team Leader

Ipsen Biopharm Ltd; Wrexham; On-site; GBP 52,000 - 70,000; Full time

Job summary

Ipsen Biopharm Ltd in Wrexham is seeking a QC Microbiology Shift Team Leader to lead a microbiology team in a highly regulated GMP environment. You will drive testing, environmental monitoring, and quality control while partnering with QA, Sterility Assurance, and Production to ensure on-time release of medicines.

The role requires a Life Science degree, strong microbiology and GMP knowledge, and proven leadership capabilities to guide investigations and continuous improvement initiatives.

Qualifications

• Degree in Life Science discipline.
• Experience in a cGMP-regulated pharmaceutical or biopharmaceutical microbiology lab.
• Strong knowledge of microbiological testing including bioburden, sterility, endotoxin and environmental monitoring.

Responsibilities

• Provide day-to-day leadership for the QC Microbiology team and ensure timely microbiological testing deliveries.
• Manage laboratory schedules, resources and priorities to ensure on-time delivery.
• Review microbiological data and environmental monitoring results for quality and compliance.
• Support batch certification and release through microbiological assessment and reporting.
• Investigate OOS, OOT and OOE events and drive CAPA actions.
• Collaborate with Sterility Assurance, QA, Production and Technical Operations on risk assessments.
• Lead continuous improvement initiatives in QC Microbiology operations.
• Monitor team KPIs and maintain audit/inspection readiness.
• Assist regulatory inspections and customer audits while promoting quality culture.

Skills

People leadership

GMP knowledge

Microbiology testing

Environmental monitoring

Education

Life Science degree

Job description

About Ipsen

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description

QC Microbiology Shift Team Leader

Location: Wrexham

Hybrid Working Available

Leadership Opportunity | GMP Manufacturing | Pharmaceutical Quality Lead Quality. Drive Compliance. Develop Talent.

Are you an experienced microbiology professional looking for your next leadership challenge in a highly regulated pharmaceutical environment? At Ipsen, we're looking for a QC Microbiology Shift Team Leader to lead a talented team responsible for critical microbiological testing and environmental monitoring activities that help ensure the delivery of safe, high-quality medicines to patients worldwide. This is an exciting opportunity to combine your technical microbiology expertise with people leadership, continuous improvement, and cross-functional collaboration in a site that places quality, innovation, and patient outcomes at the heart of everything we do.

What You'll Be Doing

As QC Microbiology Shift Team Leader, you'll provide day-to-day leadership for the QC Microbiology team, ensuring the timely delivery of microbiological testing and environmental monitoring activities while maintaining the highest standards of GMP compliance and data integrity.

You’ll be responsible for:

• Leading, coaching and developing a high-performing team of microbiologists
• Managing laboratory schedules, resources and priorities to ensure on-time delivery
• Reviewing microbiological data including bioburden, sterility, endotoxin and environmental monitoring results
• Supporting batch certification and release activities through microbiological assessment and reporting
• Driving investigations relating to OOS, OOT and OOE events
• Partnering with Sterility Assurance, QA, Production and Technical Operations teams to assess microbiological risks and support decision-making
• Leading continuous improvement initiatives across QC Microbiology operations
• Monitoring and reporting team performance through meaningful KPIs
• Ensuring audit and inspection readiness at all times
• Supporting regulatory inspections and customer audits
• Promoting a strong quality and safety culture across the laboratory

What We're Looking For

We're interested in hearing from candidates who bring both strong technical expertise and proven people leadership experience.

Essential Requirements

• Degree in a Life Science discipline
• Experience working within a cGMP-regulated pharmaceutical or biopharmaceutical microbiology laboratory
• Strong knowledge of microbiological testing including: Bioburden Sterility testing Endotoxin testing Environmental monitoring
• Experience leading investigations relating to OOS, OOT and OOE results
• Experience managing laboratory resources, schedules and priorities
• Previous experience leading, coaching or developing teams
• Good understanding of GMP requirements and regulatory expectations

Highly Desirable

• Degree in Microbiology
• Strong knowledge of EU GMP Annex 1 and ICH Q9
• Experience with contamination control strategies and aseptic processing environments
• Knowledge of isolator technology
• Experience managing CAPAs, change controls and audit readiness programmes

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us".

The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve.

If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.

At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients' lives.

We invest in our employees to support life-changing projects that create positive impact for patients and society.