Senior Scientist - CMC Process DevelopmentSenior Research Scientist – CMC, Process Development
Competitive Salary, Good Benefits
Senior Research Scientist – CMC, Process Development: Cambridge
My client is a pioneering Biotech company involved in the exploration of microbiomes for treatments related to areas such as Immuno-Oncology and Ulcerative Colitis.
As a result of the progression to clinical trials, expansion is planned and as part of this a Senior Scientist with CMC, Process Development experience is being sought.
The client’s current therapeutic focus is centered on Immuno-Oncology and Ulcerative Colitis. Excitingly, 2 assets are being progressed into clinical trials, whilst novel programmes are being progressed in Gut Epithelial Repair and in new indications; through analysis of clinical datasets. Further to this, through collaborations with public and private institutions, they are making a real difference in the Biotech world and are known as leaders in cancer microbiome space (melanoma, non-small cell lung cancer and renal cancer for instance).
What does the role entail?
* Perform experimental work and work in collaboration with external partners
* Help drive strategy in the process development team
* Work with the team to establish the lyophilisation capabilities, including processes and analytics
* Develop suitable formulations and lyophilisation cycles for the lyophilsation of live bacteria-based drugs; for transfer to GMP manufacturing organisations
* As part of the Pre-Clinical Development team, you’ll play a key role in progressing research into clinical development. The client is expanding process development capabilities, building upon its media and fermentation development platforms to cover all aspects of process development for the production of freeze-dried anaerobic bacteria for use as medicinal products to modulate the human gut microbiome
* Reporting to the Director of CMC, the role involves development of lyophilisation process for transfer to GMP contract manufacturing partners; together with supporting and trouble-shooting tech transfer activities
* Work and liase with scientists performing researching the physiology and function of novel gut bacteria
* Support the company’s interactions with sub-contracted GMP manufacturing organisations, assisting with process transfer and ongoing manufacturing technical support
* Maintain awareness of new technologies and innovations in the field of live bacterial manufacturing for incorporating into company labs
* PhD in a biological discipline – such as Microbiology or Bioprocess Engineering (or a related discipline) and/or BSc/MSc in the above area(s) and solid experience in a bioprocessing environment
* Experience in a bioprocess development environment, developing freeze-drying processes
* Knowledge in scaling freeze-drying processes for pharmaceutical manufacture for early phase clinical trials
* Expertise in freeze-drying analytics
* People skills – being a thought leader and bringing knowledge into a team as well as being willing to learn
* Background in microbiology, with experience in anaerobic bacteriology a particular benefit
* Experience of developing manufacturing processes for application in GMP manufacturing
* Experience in stability testing to support GMP manufacturing
* Understanding and/or use of tangential flow filtration systems for buffer exchange and production concentration
* Experience in the use/operation of bioreactors
What can you expect?
* A competitive starting salary
* Flexibility in working hours as much as possible
* Pension contributions
* Life & Health insurance
* 25 days holiday + 8 bank holidays
* Pathways for career progression
* Ongoing commitment to training
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