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Production Manager

Employer
KINGS COLLEGE LONDON
Location
London (Central), London (Greater)
Salary
£51,974 per annum, including London Weighting Allowance
Closing date
25 Feb 2024

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Job Details

Job description

GTFV manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) in state-of-the-art Good Manufacturing Practice (GMP) facilities for novel therapies of different cancers and rare diseases.

The Production Manager will be responsible for managing the manufacture of different types of Investigation Medicinal Products (IMPs) and “Specials” for cell and gene therapies, but especially viral vectors used in clinical trials. Part of this role will be the planning, overseeing and actively participating in as well as delegating production activities inside the cleanrooms to ensure the timely, efficient and GMP compliant manufacture of IMPs that meet agreed specifications.

The post holder is responsible for building and maintain a high performing team including managing and training of production staff. Strong interactions with the Head of Production and members of other teams like QA will be required to ensure consistent performance in compliance with the Pharmaceutical Quality System (PQS).  The post holder will conduct writing, reviewing and line approval of PQS documents such as Standard Operating Procedures, change controls, risk assessments, and batch documentation.  Leading effective investigations and implementation of CAPAs in a timely manner is a key requirement.

The post holder will be responsible for managing their workload, and that of their team, scheduling activities, making decisions independently and seeking input from senior leaders and SMEs when necessary.

The Production Manager needs to have a strong GMP and management background. That includes hands-on experience as a GMP operator, knowledge of the GMP regulations, especially for cell and gene-based therapies, and of relevant processes and systems ensuring compliance with regulatory requirements and quality standards.

This post will be offered on an indefinite contract.

This is a full-time post - 100% full time equivalent.

 

Key responsibilities

  • Leading preparation and performing GMP production campaigns for viral vector products in cleanroom facilities  
  • Communicate complex information in a clear and precise way, both orally and in writing, including writing and completing production documents (e.g. manufacturing records, SOPs, CAPAs) 
  • Performing validation activities of cleanroom and equipment 
  • Performing/overseeing process improvement experiments to demonstrate and implement improvements in manufacturing processes 
  • Provide advice and training on technical/scientific area of expertise. 
  • Work independently based on an agreed work plan, setting own priorities and those of the team, working cooperatively to achieve the service objectives. 
  • Forge relationships with colleagues in the university and externally, to disseminate and get information, coordinate and deliver the required service. 
  • Nurture and encourage sustainable practices and leadership within your team and networks. 
  • Be responsible for the compliance with Health & Safety and other relevant regulations governing the service  
  • 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.

 

Skills, knowledge, and experience

Essential criteria  

  1. Degree in Biological Sciences, preferably M.Sc/ Ph.D 
  2. Significant experience in GMP Manufacturing Operations 
  3. Knowledge and experience in working aseptically in cleanrooms 
  4. Knowledge and experience in viral vector manufacture 
  5. Significant knowledge and experience in cell culture 
  6. Significant experience in writing and reviewing of GMP-compliant documents (e.g. Manufacturing Records, Standard Operating Procedures, CAPAs, H&S documents) 
  7. Knowledge and experience in process development/transfer ideally in cell and gene therapy processes 
  8. Experience of creating training packages  
  9. Demonstrated team working ability including strong interpersonal and behavioural skills 
  10. Demonstrated problem solving skills with an analytical and planning approach considering GMP regulations.

Desirable criteria

  1. Experienced in managing projects / small teams 
  2. Experience in equipment and facility validation activities

 

Further information

This post is subject to Disclosure and Barring Service and 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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