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Process Development Group Leader in Cambridgeshire
Lead the Process Development group in the preclinical development of novel medicines comprising a consortium of live bacteria delivered orally to the intestinal tract. The successful candidate will actively contribute to the Company’s development programmes in ulcerative colitis and immune-oncology. The successful candidate will be responsible for in-house fermentation process development for multiple anaerobic gut bacteria that comprise the medicine, characterising and optimising their growth and providing support for upstream and downstream method development and optimisation.
- Leading a small team to develop fermentation processes to produce live bacterial therapeutics comprising multiple bacterial strains
- Performing anaerobic fermentation of bacteria from deep well blocks to small fermenters
- Developing media screens and optimising media for growth of metabolically diverse bacteria
- Co-ordinating outsourced lyophilisation development studies and developing an in-house capability for lyophilisation development.
- Working closely with the assay development team to develop suitable assays to assess microbial cell quality
- Maintaining an awareness of latest technologies and equipment for incorporation into company labs
- Ensuring detailed records of experiments are kept within the team, suitable for supporting regulatory filings.
- Supporting process transfer to CDMOs
Essential requirements for this post include:
- PhD in relevant discipline eg: Microbiology or Bioprocess Engineering with focus on fermentation.
- In-depth bacteriology knowledge
- Post-doctoral experience in a bioprocess development environment utilising fermentation technology
- Experience of optimising manufacturing processes and methodologies.
- Strong leadership skills (Preferable experience of leading small teams).
- Demonstrable initiative
- Excellent communication and interpersonal skills.
Desirable requirements for this post include:
- Experience of using Design of Experiments (DOE)
- Previous experience working with a microbiome therapeutic or probiotic development company
- Expertise in handling and culturing anaerobic bacteria
- Experience of developing processes for subsequent application in GMP manufacture
- Experience of process technology transfer to external companies
- Experience of lyophilisation process development
If interested please send most recent CV to firstname.lastname@example.org