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Production Manager

King's College London - Faculty of Life Sciences & Medicine - Comprehensive Cancer Centre

Location: London
Salary: £51,974 per annum, including London Weighting Allowance.
Hours: Full Time
Contract Type: Permanent
Placed On: 6th February 2024
Closes: 25th February 2024
Job Ref: 083885
 

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  

Skills, knowledge, and experience

Essential criteria  

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

Desirable criteria

  • Experienced in managing projects / small teams 
  • Experience in equipment and facility validation activities
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