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GMP Quality Control Technician

Employer
KINGS COLLEGE LONDON
Location
London (Greater)
Salary
£33,114 to £37,804 per annum, including London Weighting Allowance
Closing date
24 Oct 2021

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Academic Discipline
Biological Sciences, Life sciences
Job Type
Professional Services, Administrative
Contract Type
Fixed Term
Hours
Full Time

Job Details

Job description

The Centre for Cell and Gene Therapy (CCGT) manufactures ATMPs for a wide variety of novel gene and cell therapies for the treatment of cancers to rare diseases. This is an opportunity to work within one of the largest academic GMP facilities in  Europe focusing on the delivery of gene therapy products for early phase clinical trials.
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This role is for a qualified and trained GMP Quality Control Technician who has been working in the Quality Control department related to the development, testing and release of AAV vectors or other gene therapy products as IMPs in an academic or industry-led GMP manufacturing facility. The work will include day-to-day operations and execution of QC testing operations, ensuring the QC assay development, validation and testing schedule is followed by participating in testing and release processes, liaising with the quality and technical team, preparing of GMP quality documentation, identifying bottlenecks and reporting to the Senior QC Technician (or QC Manager). In fulfilling these tasks, a strong background in cGMP and interpersonal skills will be essential, but training (both in-house and through external courses) will be provided, as deemed necessary.
 
Role profile
As part of the role profile, the Quality Technician will be required to participate in initial site start-up activities related to facility and equipment qualification, QC validation activities leading to site readiness and GMP inspection of the AAV vector manufacturing facility including implementation of electronic quality system and batch record documentation, and be trained in the manufacturing and release of gene therapy products at Guy’s or Denmark Hill campus. Further, the post holder may be required to take an active role in other projects within the CCGT group, and will execute experiments independently or in collaboration with other group members, as required by manager or head.


The postholder will have expertise working in a GMP licensed facility and be trained in cell culture, molecular and analytical techniques, QC development, validation of quality control assays for in-process, stability and release testing. The post holder will be trained in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and product specification file, reviewing electronic batch and quality records for quality approval, batch certification and QP release. They will be trained in performing assigned duties within a team and interacting with QC staff performing analytical testing (QC assay development and validation) operations, for process/analytical assay optimisation and development, validation, manufacturing, QC testing and release of products for clinical trials.
 
This post will be offered on a fixed-term contract for 30 months
This is a full-time post - 100% full time equivalent

Key responsibilities

In the Centre for Cell & Gene Therapy at Guy’s and Denmark Hill campus
 

  • Perform operations related to QC testing as an active member of CCGT working on the development and release of cell and gene-based therapies.
  • Develop and execute QC procedures for implementation and approval for cGMP compliance
  • Demonstrate a commitment to ongoing professional development, complete own periodic staff qualification and training records related to manufacturing procedures.
  • Engage and undergo relevant training and manage training of staff in accordance with approved Training Matrix and as required for GMP compliance. Continually update knowledge and understanding in the field of cell and gene therapy.
  • Perform routine activities related to QC assay development and validation for QC release testing for intermediate/bulk/final product and stability testing of development, pre-clinical and clinical batches.
  • Perform assigned tasks in the execution of site start-up activities related to facility and equipment qualification, qualification procedures for cleaning and disinfection, environmental monitoring and decontamination operations, analytical development and validation activities, transfer of analytical procedures to third party sponsors and ensure completion of staff training
  • Pro-actively support the quality team in the development and execution of electronic quality assurance operations related to Pharmaceutical Quality System compliance, electronic design history records and electronic supplier management system
  • Assist and support other members of the group, using a systematic and timely approach to solve problems , while handling multiple projects to ensure continued GMP manufacturing and release of gene therapy products.
  • Actively support team responsible for ensuring timely execution and completion of QC assays during the GMP manufacturing process.
  • Support team in the use of validated manufacturing or analytical equipment, providing training where required.
  • Provide cover the absence of key QC staff in CCGT group
  • Manage own workload and resources based on an agreed work plan for achievement of project aims whilst also being responsive to changing priorities.
  • Use well-developed analytical skills to identify trends and patterns, using appropriate techniques and procedures to inform decisions and ensure product quality, patient safety and GMP compliance.
  • Ensure work complies with PQS and set high quality standards for service and execution.
  • Complete and submit up-to-date, accurate and comprehensive documentation records and laboratory reports, where applicable.
  • Communicate complex information in a clear and precise way, both orally and in writing.
  • Prepare and submit laboratory reports.
  • Generate and provide data/results for a variety of tasks including presentations at regular GMP lab meetings, seminars, manuscripts, national or international meetings and to support improvement in analytical validation and testing.
  • Attend and contribute to team meetings for periodic review and progress.
  • Actively contribute to decisions affecting performance and in meeting objectives of the team
  • Work closely with the development department to ensure testing of development and pre-clinical batches and communicating with key stake-holders
  • Forge relationships with colleagues in the university and externally, to build relationships, disseminate and get information, coordinate, and deliver the service
  • Provide advice/ guidance and, where appropriate, training. For new staff in the conduct of individual and collaborative research projects.
  • Demonstrate leadership and innovation in the implementation of environmentally sustainable practices, recording progress through the King’s sustainability audit process and sharing good practice.
  • Nurture and encourage sustainable practices and leadership within your team and networks.
  • Facilitate an inclusive culture and ethos working with academic, research and other professional services staff and colleagues external to King’s.

 
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
A more comprehensive overview of the key responsibilities may be requested from Heather Kneale –   heather.kneale@kcl.ac.uk.
 
Skills, knowledge, and experience


Essential criteria


Qualifications and Training
1.       Minimum level 6 qualification, e.g. relevant undergraduate degree or equivalent, in Biological discipline related to life sciences OR considerable knowledge and skills gained through work experience, with GMP training and ATMP QC testing experience for the release of viral gene therapy products as IMPs/INDs for clinical trials (AP, I).
2.       Background in analytical cellular and molecular techniques, and trained as Quality Control Scientist for GMP manufacturing, leading to release of gene/cell therapy IMPs/ MS products in a licensed GMP facility in university or industry (AP, I)
3.       Trained in QC assay optimisation and development, analytical assay development, analytical validation and testing of MCB/WCB, gene/cell therapy products for pre-clinical and clinical trials in a reputed academic organisation or industry (I, with a commitment to ongoing professional development
 
Skills / Experience
4.       Experience in QC related operations in a licensed GMP facility with a good working knowledge of regulations and best practice governing cGMP compliance including qualification of staff and equipment, in addition to approved QC procedures for use in GMP manufacturing and product release (I).
5.       Experience in working with quality team ensuring document control, training records, validation including calibration and maintenance, audit, change control, deviations, CAPA, OOS, quality risk management, supplier qualification and approval, etc are in compliance with PQS (I).
6.       Experience in (i) development and qualification of QC assay procedures for in-process and QC product release testing, (ii) preparation for internal, external and regulatory audits, executing operations leading to GMP inspection readiness and approval (I).
 
Knowledge
7.       Working knowledge of EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, current MHRA Orange Guide  including EU GMP regulations for ATMP manufacturing for clinical trials (AP, I)
8.       Awareness or knowledge in compiling QC Validation Master Plan covering aspects of in-process, internal and external QC testing requirements as per Ph.Eur guidelines, and Batch Manufacturing Record for QP review and release (I).
9.       Knowledge of the field of gene and cell therapy, and expertise in translational research methodology with an organised and systematic approach to development and manufacturing (I).
 
Competencies
10.   Trained in relevant analytical cellular and molecular techniques for testing of gene therapy vectors (I).
11.   Competent in completing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products (I).
12.   Clear spoken and written communication skills, strong interpersonal skills dealing with internal and external stake-holders, good record keeping and attention to detail, ability to contribute to the team success such as training colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab and GMP facility (I).
 
Desirable criteria
1.       Experience in supporting quality control and assurance team for implementation of electronic quality documentation (AP, I).
2.       Experience in analytical development, testing and release of AAV gene therapy products in ongoing clinical trials.
3.       Experience in GMP facility start-up from facility and equipment qualification to development, validation and GMP manufacturing, and handled AAV gene therapy projects successfully from pre-clinical testing to batch manufacturing, CMC documentation and IMPD/IND approval (AP, I).
4.       Experience in working with quality control team, comprising of development, QC and quality assurance staff for coordinating milestones related to quality assurance, QC development, audits (internal, external and regulatory), and assisted in providing relevant information to internal and external stake holders, leading to GMP inspection readiness and approval (AP, I).
5.       Experience in working with a team to meet agreed timelines for testing and release of gene therapy products for clinical trials, providing support beyond code hours when required (AP, I).
 
This post is subject to a Occupational Health Clearance. 

Company

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

Company info
Mini-site
KINGS COLLEGE LONDON
Telephone
+(44)02078365454
Location
STRAND
LONDON
WC2R 2LS
United Kingdom

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