Job description

Senior Quality Control Manager

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

SENIOR QUALITY CONTROL MANAGER

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

This Senior Quality Control Manager role is to lead and manage the Immunocore QC Scientists, developing and maintaining GMP compliant laboratories and operating systems, delivering results with robust data integrity to ensure trusted regulatory submission content & product stability evaluation supporting patient safety. Input to designing long term QC strategies and championing continuous system improvements are also within scope.  

Responsibilities:

  • Establish and realisation of a high performing, right-first-time, metrics driven QC GMP team.
  • Line management, including performance appraisals of QC GMP laboratory team members, driving their ownership and accountability for operational excellence within the QC testing operations and laboratory maintenance.
  • Support appropriate development, and training of team members, particularly through priority task delegation and growth opportunities in their scientific roles.
  • Champion the interface and collaboration of QC Scientists with Analytical Development for supporting method troubleshooting, remediation, transfers & validation.
  • Manage Product stability evaluation and reporting, in support of shelf-life strategies.
  • Build a culture of ownership for both Health & Safety and GMP compliance within the QC laboratory and team activities.
  • Oversight of QC facility and Equipment validation activities and documentation.
  • Execute method transfers and validation to support GMP testing at Immunocore, in accordance with local procedures.
  • Author and / or review QC procedures, ensuring robust and compliant systems.
  • Monitor and communicate requirements for method remediation to Analytical Development, based upon method performance metrics, and collaborate to resolve performance issues.
  • Ownership of QC cold chain compliance and traceability for GMP test samples (IPC, DS, DP) from receipt through to reportable results.
  • Oversight of compliant GMP stability testing in Immunocore laboratories in accordance with study protocol requirements.
  • Lead evaluation and reporting of Stability testing & trending, delivering reports and Regulatory input in support of active shelf-life strategies.
  • Author and / or review study protocols and reports.
  • Support compilation of clearly documented Quality investigations and efficient closure metrics for all Quality Events (OOSs, Deviations, Change Controls) owned by the Immunocore QC GMP laboratory team.
  • Provide technical SME input to QC method troubleshooting within scope of experience, driving additional collaboration with Analytical Development SMEs to ensure robust remediation, Qualification & validation packages are delivered throughout method lifecycles.
  • Participate in QA audits (internal and external), as required.
  • Proactive approach to QC interactions with cross-functional stakeholders, ensuring appropriate communication and visibility of system deliverables.
  • Input to continuous QC system & process improvements.
  • Champion Health and Safety initiatives within the team of QC Scientists, providing ad-hoc training as required, and reflecting Immunocore’s H&S culture and related non-GxP policies.

Qualifications: 

Essential

  • Proven knowledge of GMP and Regulatory requirements.
  • Experience in Quality Management Systems.
  • Experience of establishing and improving systems for QC GMP operations.
  • Technical experience in Analytical assays for release, stability and / or characterisation testing of Biological Drug Products.
  • Practical experience of analytical validation & technology transfer.
  • Proven experience in QC Specifications setting, stability design and Product shelf-life.
  • Owned real time evaluation, trending, and output for product stability studies.
  • Led Quality investigations and compliance events (OOS, non-conformances, change controls).
  • Experience of regulatory agency GMP audits and auditing 3rd parties.
  • Experience with line management of a team of QC stability scientists, scheduling & prioritising workload, ensuring the provision of a high level of Health & Safety and fit-for-purpose risk and COSSH assessments.
  • BSc. Or MSc. in biological science or related discipline.

Desirable

  • Knowledge of equipment validation requirements.
  • Managed external QC testing, including input to contracts & quality agreements.
  • Experience of process validation programs for biopharmaceuticals.
  • Higher degree in biological science or related discipline.

Lead with Science and Discover What is Within:

  • We Value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Private medical and dental benefits.
  • 25 days Annual Leave and Bank Holidays
  • 4x Salary Life Insurance
  • 5% Pension Match
  • Income Protection
  • Parental Leave

 

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