Job Description
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
* Participate in and lead key technology transfers activities, supporting clinical and commercial new product introduction projects.
* Develop strategies for and support the execution of technology transfer, process, and clean validation programs, adhering to company, industry, and regulatory standards.
* Act as a Process Subject Matter Expert in supporting process investigations.
* Utilise risk management techniques to assess strategies, prioritise activities, and initiatives.
* Lead significant business-critical projects on-site associated with new product introduction and site capability build.
* Act as System Owner and Subject Matter Expert (SME) to support investigations, utilising 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 Bachelors Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with experience in the biotechnology or pharmaceutical industry.