Process Development Scientist

Process Development Scientist Job Description Template

Our company is looking for a Process Development Scientist to join our team.


  • Creation and maintenance of all relevant cGxP documents;
  • Perform the following established procedures including, but not limited to, cell culture (adherent/ Suspension), and exosome harvest;
  • Identify improvement opportunities in existing processes, providing metric indicators measuring impacts;
  • Some experience with cell line development / clone selection / media optimisation with Ambr15;
  • The Scientist will be required to communicate verbally and in writing within the CMC group;
  • Execute good documentation practices;
  • Offer suggestions for resolution of technical issues based on experience. The scientist will be expected to show creativity in resolving issues;
  • Some experience with up-stream process development;
  • Identify, source and qualify equipment to required standards supporting GMP manufacturing;
  • Review the effectiveness of current processes and provide input into process improvements;
  • Produce exosome harvest (team Supply) to support downstream process development and process characterisation;
  • Support technology transfers from R&D to first in man and from IPS to Commercial;
  • Maintain and provide in-depth knowledge and expertise in GMP product manufacture, facilities and equipment;
  • Some experience with bioreactor use for large scale-ups.


  • Proven communication skills including completing written reports and an ability to present;
  • Proven scientific knowledge of process scale up;
  • Experience in a relevant laboratory environment;
  • BSc or MSc in Biological Sciences/cell biology;
  • Experience of working within a regulated GMP environment;
  • Demonstrated aptitude for project management;
  • Excellent attention to detail.Demonstrated aptitude for risk management;
  • Experience of operating Bioreactor systems (Stirred tank / hollow fibre / Wave systems);
  • Degree or experience in relevant discipline such as chemistry, process chemistry, pharmaceutical science, engineering or another relevant subject;
  • Experience in equipment qualification and validation;
  • Collaborative team player developing positive working relationships with others;
  • Must have experience of operating Ambr15 for clone selection.