Process Development Scientist

Updated: about 2 months ago
Location: Harrow N W and S, ENGLAND
Deadline: 07 Mar 2024

Job id: 084627. Salary: £42,099 per annum, including London Weighting Allowance.

Posted: 15 February 2024. Closing date: 07 March 2024.

Business unit: Faculty of Life Sciences & Medicine. Department: Comprehensive Cancer Centre.

Contact details:Kinga Nowicka. [email protected]

Location: Guy’s Campus. Category: Professional & Support Services.


Job description

The 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.

This post is subject to Disclosure and Barring Service clearance.


Key responsibilities

Communication & Networking

  • Conveying and understanding 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.
  • Initiating, building and leading internal and external networks and maintaining 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, interpreting requirements and supporting junior staff in delivery of service.

Analysis

  • Gathering and analysing data so it can be interpreted by others for inclusion in reports or other documents.

  • Identifying and selecting the most appropriate procedure/ technique to conduct analysis to aid decision making.

  • Assisting other teams and junior staff to acquire and interpret data.

  • Collating and analysing data to determine process performance, trending to identify issues.

Teamwork, Teaching & Development

  • Sharing specialist knowledge of a particular area/ aspect of work and act as subject matter expert.
  • Ensuring other team members are informed of new process developments, technologies and techniques and leading training as required.

Measures of success

  • Technical knowledge in process development.
  • High degree of compliance with regulations.
  • High level of teamwork.
  • Contribution to sustained growth of manufacturing activities through improved processes.

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

  • B.Sc/ M.Sc/Ph.D degree in a relevant science, engineering or life science discipline.
  • Experience working in commercial companies within GMP Pharma/Biotech/Contract Manufacturing organisation (CMO) sectors.
  • 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.
  • Experience in development of biopharmaceutical processes, quality compliance, process development/qualification, control strategy.
  • Contributing to safety and quality risk assessments.
  • Experience of managing change through GMP change control system 8. 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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