This is an 11 month contract with a view to extension

Purpose

An exciting opportunity has arisen for a MS&T Senior Bioprocess Engineer. This position will be part of the MS&T team at our state of the art single-use multi-product commercialisation biotech site.

Responsibilities

• Responsible for the participation in and leading of key technology transfers activities, in support of clinical and commercial new product introduction projects.
• Development of strategies for and support in the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
• Acting as process Subject Matter Expert in the support of process investigations.
• Use of risk management techniques to assess strategies, prioritize activities and initiatives.
• Lead other significant business critical projects on site associated with new product introduction and site capability build.
• Acting as system owner and Subject Matter Expert (SME) to support investigations and using risk management techniques to prioritize activities and initiatives.
• Ongoing optimization of process equipment and development of future breakthrough business solutions.

Qualifications

• Minimum of 6 years in a biologics drug substance environment
• Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
• Experience in technology transfers for clinical or commercial biologics strongly desired.
• Experience with automated systems highly desired
• Process validation and cleaning validation experience desired.
• Minimum of a Bachelor’s Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with experience in the biotechnology or pharmaceutical industry.