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Support all steps of the monoclonal antibody production process and aid the manufacture, optimisation, scale-up and validation of the process.
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Liaise with external service providers to provide the correct technical support for successful transfer of the process into the facility contributing to the overall successful completion of assignments.
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Coordinate the writing of Batch Manufacturing Records, SOPs and other quality system documentation required for GMP manufacture.
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Assist with hands-on technical support such as buffer/media preparation, cell culture and purification processes as part of the manufacturing activities.
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Provide technical input and support writing of technical reports necessary for regulatory purposes.
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Participate in Quality and Safety regulatory audits.
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Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.
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Diploma in Biochemistry, Chemistry, Process Engineering, or equivalent experience.
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2-5 years’ proven experience in Bioprocess development or manufacturing.
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Experience in Cell culture, protein purification, lab-scale and pilot scale.
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Ability to work with bioreactors, chromatography systems and filtration systems.
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Working in a controlled and regulated GMP/GLP environment.
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Knowledge of analytical methods required for protein characterisation.
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Knowledge of key suppliers of disposable systems, process materials and equipment.
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Relevant Experience collaborating with external contractors and excellent project management ability.
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Ability to maintain clear records of deadlines and work being completed, highly developed verbal and written communication skills.
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Experience working effectively as part of teams across various departments in the organisation.