Associate Scientist – 12 month contract with minimum 12 month extension
You will work in a team environment, collaborating with various process scientists (upstream and downstream) and analytical scientists. You will utilize knowledge in biochemical engineering, chemical engineering, statistics, molecular biology, analytical methods and cellular metabolism to aid in process development and optimization of upstream processes producing protein therapeutics for early and late stage projects. This will include but may not be limited to process troubleshooting investigations, process characterisation studies, evaluation of cellular responses to process operations, assessment of effects on product quality, determination of process scalability and tech transfer to GMP facilities.
You will be predominantly laboratory based and will be involved in experiments with bench-scale reactors (disposable 250mL and glass 5L), pilot scale 200L stainless steel and single use bioreactors and associated disk stack centrifugation and pilot scale harvest equipment. You will apply Quality by Design (QbD) principles utilizing Design of Experiment (DoE) methodology and be responsible for some planning of activities, analyzing laboratory data and reporting back to project leader/line manager and team members on a regular basis. You will produce accurate, traceable records of work using batch records, protocols and electronic lab notebooks, generating documentation for experimental reports to support technology transfer and regulatory filings.
You will undertake a range of purification and analytical biochemistry techniques, utilising high throughput technology platforms such as Tecan robotic systems in order to understand the impact of fermentation and primary recovery parameters on process performance, biology of the cells, impact on downstream processing and product quality attributes. Where required, you will work closely with in-process analytical colleagues and participate in method troubleshooting and method development. You will also be expected to contribute to scientific development and technology development projects requiring innovative research, in order to improve USP and primary recovery processes and understanding.
Educated to at least degree level, you will have a good theoretical knowledge of fermentation and/or cell culture systems, gained both during your degree and ideally within an industrial environment. You will be a proactive individual, able to demonstrate problem solving skills and have the ability to recognise and identify issues for scientific development. Above all you will have a proven aptitude for laboratory work and the ability to execute and apply scientific knowledge.
1) Perform, with support, upstream process development experiments for the development of new manufacturing processes and the improvement of existing processes at lab and pilot scale, including all upstream and primary recovery activities as well as associated analytical methods.
2) Trend and analyse laboratory data and present results to line manager, USP team and at internal meetings as appropriate
3) Help determine process limits as part of process understanding, characterisation and validation studies.
4) Provide traceable records of lab work, experimental design and report writing (e.g.Batch records, lab notebooks, protocols, reports)
5) Contribute to the development of new technologies within the USP team and where possible contribute to the development of intellectual property.
6) Aid with reviewing, writing and updating internal procedures and documents (e.g. Lab procedures, SOPs, templates)
7) Contribute to the maintenance and housekeeping of a safe laboratory working environment, including contribution to writing and reviewing HSE risk assessments related to USP activities.
8) Promote a good interface with other BTS teams by providing updates of work and project progress to technical teams and project meetings as required.
9) Aid with providing technical expertise in upstream processing for internal customers (e.g. New Meds, DSP, Analytical Sciences Biologicals, QA, RA, Bio CMO Management).
• Aim to become technically expert in the operation of lab and pilot scale fermentation and cell culture processes, including the use of relevant operating control software
• Aim to become technically expert in the operation of primary recovery processes such as periplasmic extraction, continuous centrifugation and filtration.
• Aim to become technically expert in analytical methods associated with analysis of cells and product (Cell viability, HPLC methods, plate-based colorimetric and fluorometric assays, affinity purification using TECAN, SDS PAGE)
• Ability to develop a high level of capability in designing and performing process development experiments as well as excellent data interpretation, drawing of conclusions and proposals for further work
• Experience with high throughput technologies, automation, miniaturisation, statistics and/or programming is preferred
• Ability to learn and use appropriate data management concepts and tools
• Sound understanding of microbial and/or CHO physiology