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Senior Process Development Scientist

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

Location: London
Salary: £43,205 to £46,732 per annum, including London Weighting Allowance
Hours: Full Time
Contract Type: Permanent
Placed On: 6th February 2024
Closes: 25th February 2024
Job Ref: 083906
 

Job description

The Senior Process Development Scientist for the Gene Therapy Vector Facility (GTVF) is a new role within the Process Development function.  The post holder will work closely with colleagues in Production, Quality Assurance, Quality Control, to ensure manufacturing processes are evaluated and optimised to allow efficient operation and delivery of products for client projects.

The successful candidate will be leading projects/ programme of work under the direction of the Head of Process Development.  The post holder will be responsible for technical evaluation of client proposals, proposing targeted lab work to optimise processes prior to manufacture, supporting risk assessments, biological safety evaluation and identifying and implementing improvements in manufacturing and analytics and evaluating new technologies to improve manufacturing capabilities.

This post will be offered on an indefinite contract.

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

Key responsibilities

Communication & Networking

  • Convey and understand communication of a highly complex or conceptual nature. 
  • Clear and precise communication of experimental plans and results to internal and external stakeholders.  Choosing an appropriate method of delivery and employing techniques to ensure understanding. 
  • Initiate, build and lead internal and external networks and maintain on-going relationships with customers, suppliers and external agencies.

Decision Making, Planning & Problem Solving

  • Be able to take independent decisions and contribute to collaborative decisions that have implications for their work and that of others. 
  • Be able to manage own workload and resources and prioritise to achieve objectives. Be responsible for planning and leading projects/ work streams ensuring effective resources are allocated.  Inputting into longer term planning. 
  • Able to resolve problems which maybe complex and require application of initiative and creativity.  Proposing various solutions and evaluating options may be required.

Service Delivery

  • Responsible for providing and assisting in setting the standard of service. Interacting with internal and external stakeholders, interpret requirements and support junior staff in delivery of service.

Analysis

  • Gather and analyse data so it can be interpreted by others for inclusion in reports or other documents.  Identify and select the most appropriate procedure/ technique to conduct analysis to aid decision making.  Assist other teams and junior staff to acquire and interpret data. 
  • Collate and analyse data to determine process performance, trending to identify issues.

Skills, knowledge, and experience

Essential criteria  

  • B.Sc/M.Sc/Ph.D degree in a relevant science, engineering or life science discipline  
  • Significant experience working in commercial companies within GMP Pharma/Biotech/Contract Manufacturing organisation (CMO) sectors 
  • Significant experience with a range of biopharmaceutical and cell-based processes and techniques including cell culture and purification techniques 
  • Significant experience gained in Process Development in a number of processes used in viral vector manufacturing demonstrating optimisation of processes delivering improvements in yield, quality and manufacturability 
  • Significant experience in development of biopharmaceutical processes, quality compliance, process development/qualification, control strategy 
  • Leading safety and quality risk assessments  
  • Significant experience of managing change through GMP change control system 
  • Significant experience of technology transfer covering donor and receiving site activities 
  • Excellent verbal and written communication skills 
  • High level of work organization, self-motivation, drive for performance and improvement and flexibility in approach and attitude 
  • Comfortable working independently and building professional networks

Desirable criteria

  • Understanding of and familiarity with regulatory guidance governing cell-based and biopharmaceutical development 
  • Application of DoE to process development 
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