MS&T Senior Bioprocess Engineer Opportunity
This is a fantastic opportunity to be part of a fast-paced project, with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This project is truly exciting, as it will contribute to the manufacturing of a life-changing treatment when complete.
Key Responsibilities:
* Participate in and lead key technology transfer activities, in support of clinical and commercial new product introduction projects.
* Develop strategies for and support in the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
* Act as process Subject Matter Expert in the support of process investigations.
* Use 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.
* Act 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.
Desirable Experience:
* Extensive experience in a biologic 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 biologic 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.