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Open nowFirst seen 3 days ago

Interim Quality Control Lead

Cell and Gene Therapy Catapult1 open role

Where
Stevenage, Hertfordshire
Work mode
On site
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Your applicationOpen nowInterim Quality Control LeadCell and Gene Therapy Catapult · Stevenage, Hertfordshire

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Share of postings closed within
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  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 3 days ago

The posting

The Interim Quality Control Lead will support Quality Control activities across both CGT Catapult Manufacturing Innovation Centres (MIC's), GMP Quality Control Laboratories, and associated infrastructure. Reporting to the Head of Quality Control, the post holder will help ensure that the MICs operate to the standards and expectations of its key stakeholders, regulatory authorities, and both potential and existing Collaborators, while providing effective operational leadership of the Quality Control activities across both sites.

Key Responsibilities

  • Oversight of Quality Control Service services, including environmental monitoring, microbiology, raw material testing, in-process testing, and final product testing
  • Establish, review, and monitor key performance indicators and trend analysis tools to measure of Quality Control performance, including individual and team performance
  • Ensure the Quality Control operation meets all Regulatory, Quality, HS&E policies and procedures such that employees, visitors, Collaborators, and the environment are protected from significant risk
  • Focus on continuous improvement opportunities for the Quality Control operation and create a proactive culture of continual improvement within Quality Control, maintaining an audit ready environment
  • Work within the CGT Catapult MICs' multidisciplinary team and matrix environment to ensure successful delivery of CGT Catapult and Collaborator projects
  • Liaise with Collaborators and other CGT Catapult teams to ensure resources are used efficiently and effectively
  • Establish links with external organisations to benefit the CGT Catapult MICs' Quality Control processes including identifying, evaluating, and implementing innovative technologies where appropriate
  • Act as the Subject Matter Expert for environmental monitoring and biosafety testing across CGT Catapult MICs
  • Maintain a portfolio of pharmacopoeial tests within Quality Control
  • Assist in the development of Quality Control equipment and analytical method validation protocols and reports associated with biosafety testing, including detection of mycoplasma by PCR, endotoxin, microbial contamination by direct inoculation, and microbial contamination by BacT/Alert
  • Provide oversight of Quality Control analysis to ensure the Quality Control service provision associated with biosafety testing of excipient, in process, and final product samples is maintained in line with Collaborator requirements
  • Review and approve biosafety assays and environmental monitoring results.
  • Assist in the review and reporting of process trending data for Quality Control activities
  • Support Out of Specification investigations, providing subject matter expertise in the investigation of Quality Control result excursions
  • Provide leadership and line management to a growing team of Quality Control Specialists and Technicians
  • Oversee Quality Control scheduling and resource allocation to ensure efficient operation
  • Manage and close Quality Records (Non-conformances, CAPAs, and Change Controls) pertaining to the Quality Control department
  • Emphasising and maintaining a strong GMP knowledge base and work ethic within the CGT Catapult MIC teams
  • Provide technical training and coaching to the Quality Control team
  • Support relevant stakeholders with project delivery and project management
  • Act as the Quality Control representative in managing Collaborator requests, contributing to Additional Input Agreements, and liaising with Collaborators and Project Managers
  • Provide support for aseptic process qualifications, such as aseptic gowning, good aseptic practices, and media fills
  • Quality Control Sample Management and LIMS Management
  • Work with the Quality Control Laboratory Compliance Manager to monitor the Sample/Stock Management function to ensure the Quality Control team provides a timely, effective, and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage, and lifecycle management of Collaborator and CGT Catapult derived microbiology and environmental monitoring samples requiring testing
  • Provide oversight of raw material sampling activities and ensure they are undertaken in accordance with GMP and Collaborator requirements
  • Support the continued use of the Quality Control department's electronic Laboratory Information Management System (LIMS) in accordance with GMP requirements
  • Regulatory Compliance • Provide support to ensure the Quality Control team operates to high standards and complies with cGMP and other applicable regulatory standards
  • Provide support to ensure all Quality Control laboratory equipment is maintained fit for purpose through appropriate qualification, calibration, and periodic maintenance
  • Generate, review, and approve cGMP documentation, including Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports

Skills, Knowledge and Expertise

Experience:

  • Experience in interacting with clients and Collaborators is essential
  • Demonstrable experience in managing research and development projects in an academic or industry environment to delivery
  • Experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment, operating according to GMP
  • Experience of writing, executing, and reviewing GMP documents and processes, including validations, autonomously
  • Experience of working in grade B/C cleanroom in a GMP facility
  • Experience of working with relevant laboratory test platforms including operation and troubleshooting e.g. MALDI-TOF, FACS, ELISA, Endotoxin testing, Sterility testing, qPCR, ddPCR, Cell viability testing etc. in a commercial setting would be desirable
  • Experience of managing a team of Quality Control professionals
  • Experience in interacting with the regulatory authorities is desirable

Knowledge / Skills / Competencies:

  • Highly motivated, pragmatic, and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK
  • Desire to establish a high-profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success
  • High-level interpersonal, communication (oral and written) skills and emotional intelligence
  • A “roll your sleeves up” hands-on attitude towards varying work assignments
  • Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment, with a strong attention to detail
  • Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities
  • Managerial skills, regulatory knowledge and experience in the cell and gene therapy sector
  • A good team player with a hands-on approach, and adaptable to new challenges
  • Proficient in Microsoft 365 applications and general IT systems
  • Flexibility towards work assignments and new learning
  • Ambitious, collaborative, driven
  • Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks
  • Understands financial strategies including scenarios, risk management, to avoid resource wastage
  • Understands influencing and stakeholder management
  • Comfortable operating autonomously once goals and objectives are set
  • A positive attitude towards learning, personal and professional development
  • Keeps up to date with professional knowledge, expertise and best practice.
  • Willingness to travel

Education / Qualifications:

Masters or Bachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline

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