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