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 participating in and leading 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, prioritise 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 prioritise activities and initiatives.
* Ongoing optimisation 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.