Process Scientist

Role Purpose

The role will include responsibility for the manufacture and validation of processes. This will include working with teams, both on site and externally with Contract Manufacturing Organisations for some of the process development activity and for technical transfer of the process into the facility.

Duties & Responsibilities

• To support the manufacture, optimisation, scale-up and validation of all steps in the monoclonal antibody production process.
• Work with external service providers (CMOs) to provide the necessary technical support for successful completion of projects, including the transfer of the process into the facility.
• Support the writing of Batch Manufacturing Records, SOPs, and other quality system documentation required for GMP manufacture.
• Provide hands-on technical support for all manufacturing activities, including buffer/media preparation, cell culture and purification processes.
• Provide technical input and support writing of technical reports required for regulatory purposes.
• Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.

POSITION SPECIFICATION

Qualifications, Experience, Skills, Knowledge and Attributes

• BSc, MSc, PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience.
• 2-5 years' relevant experience in bioprocess development and/or manufacturing
• Cell culture and/or protein purification, lab-scale and pilot scale
• Skills with bioreactors or chromatography systems, filtration systems.
• Working in a controlled regulated environment e.g. GMP/GLP.
• Knowledge of analytical methods required for protein characterisation.
• Knowledge of key suppliers of process materials and equipment, including disposable systems.
• Experience working with external contractors.
• Excellent project management capability.
• Excellent verbal and written communication skills. Ability to maintain very clear records of work completed.