Senior Scientist - CMC, Process Development
The company is building its process development capability the fermentation and lyophilisation of anaerobic bacteria for use as medicinal products to modulate the human gut microbiome. Reporting to the Director of CMC, the role involves development of manufacturing processes for transfer to our GMP contract manufacturing partners, together with supporting and troubleshooting tech transfer activities. The work will involve close liaison with scientists researching the physiology and function of these novel gut bacteria. There will be an opportunity to both perform experimental work in the company's well-equipped laboratories and to work in collaboration with external partners.
The major areas of responsibility are to:
* Play a key role in driving strategy within the process development team * Work with other members of the team, to establish the company's lyophilisation capabilities,
* Develop suitable formulations and lyophilisation cycles for the lyophilisation of live bacteria- based drugs, for transfer to GMP manufacturing organisations
* Support the company's interactions with sub-contracted GMP manufacturing organisations, assisting with process transfer and ongoing manufacturing technical support
* Critically review and summarise internally and externally generated data for dissemination within the group
* Liaise with research microbiologists to understand the physiological requirements of novel gut bacteria, informing process development
* Report progress to program/project teams as required * Document experimental work to meet the requirements of appropriate guidelines and
regulations * Maintain and prepare equipment * Maintain an awareness of new technologies and innovations in the field of live bacterial manufacturing for incorporation into company labs
Essential Scientific Skills and Experience
* A PhD in a relevant discipline (eg: Microbiology or Bioprocess Engineering or a closely related subject) with further industry experience, or a BSc/MSc in Microbiology or Bioprocess Engineering and five plus years of experience in a bioprocessing environment
* Experience in a bioprocess development environment, in upstream or downstream process development, preferably both
* Good biochemistry knowledge, as applied to bioprocessing
* Experience in the development of bacterial bioprocesses
TGI Life Sciences is acting as an Employment Agency in relation to this vacancy.