Scientist Upstream Process Sciences - United Kingdom
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- 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 fermentation processes producing protein therapeutics for early and late stage projects.
- This will include but may not be limited to process troubleshooting investigations, process characterization 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), plus 20L & 200L stainless steel fermenters, associated disk stack centrifugation and pilot scale 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 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, utilizing high throughput technology platforms such as 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.
- Perform microbial fermentation 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 purification and analytical methods.
- Trend and analyse laboratory data and present results to line manager, USP team and at internal meetings as appropriate.
- Help determine process limits as part of process understanding, characterisation and validation studies.
- Provide traceable records of lab work, experimental design and report writing (e.g. Batch records, lab notebooks, protocols, reports).
- Provide technical expertise in upstream processing for internal customers (e.g. New Meds, Downstream Process Development, Analytical Sciences, Quality Assurance, Regulatory Affairs, Contract manufacturing Management)
- Provide upstream processing support to internal manufacturing, CMO and technology transfer teams as appropriate
- Managing placement students and/or associate scientists as appropriate (depending on experience)
- Promote good collaboration with company teams by providing updates of work and project progress to technical teams and project meetings as required.
- Contribute to the development of new technologies within the USP team and where possible contribute to the development of intellectual property.
- Aid with reviewing, writing and updating internal procedures and documents (e.g. Lab procedures, SOPs, templates).
- Contribute to the maintenance and house keeping of a safe laboratory working environment, including contribution to writing and reviewing HSE risk assessments related to USP activities.
- Education: Master Degree or PhD in biochemistry, molecular/cell biology or biochemical engineering with a number of years’ experience in process development/manufacturing sciences
- Excellent written and verbal English skills
- Demonstrated understanding and skill in microbial/mammalian cell culture and aseptic techniques
- Experience in the operation and analysis of various bioreactor/fermenter systems (Ambr250, glass STR, stainless steel STR) at multiple scales, including the use of relevant operating control software
- Experience in analytical methods associated with analysis of cells and protein product (Cell viability, HPLC, plate-based colorimetric and fluorometric assays, affinity purification using TECAN, SDS PAGE) is preferred
- Strong laboratory skills and a track record of spending >50% of current and past work function in the laboratory
- Capability to design and perform fermentation experiments as well as excellent data interpretation, drawing of conclusions and proposals for further work, plus the ability to structure, process and communicate large amounts of data
- Ability to troubleshoot upstream technical issues using rational thought processes based on process and equipment knowledge and understanding and reacting to such issues in a calm, controlled manner to provide or contribute to a solution.
- Experience with cGMP and large-scale manufacturing equipment and practices and/or experience with technology transfer to cGMP facilities is preferred
- Experience with high throughput technologies, automation, miniaturisation, statistics and/or programming is preferred
- Ability to learn and use appropriate data management concepts and tools
- Ability to author and approve comprehensive and accurate SOPs, protocols and reports
- Ability to work in matrix and virtual teams across geographies and time-zones
- Ability to maintain good working relationships with internal customers/partners
- Experience in effectively managing placement students and/or associate scientists is preferred
- Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
- Ability to prioritise own work and understand how this fits with the wider priorities of the upstream team and ongoing projects
- Ability to think creatively and critically to discover process improvements
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