Role Description
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 facility at Dunboyne Biologics.
Key Responsibilities:
* Participate in and lead key technology transfers activities to support clinical and commercial new product introduction projects.
* Develop strategies for and execute technology transfer, process, and clean validation programs in line with company, industry, and regulatory standards.
* Act as Process Subject Matter Expert in supporting 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 using risk management techniques to prioritise activities and initiatives.
* Ongoing optimisation of process equipment and development of future breakthrough business solutions.
Requirements:
* Minimum 6 years' experience 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.
Qualifications & Education:
1. Minimum of a Bachelor's Level 8 degree in a technical field (e.g. Engineering, Science or equivalent).
2. Experience in the biotechnology or pharmaceutical industry.
3. Skills: Technology Transfer, Process Investigations, Upstream, Downstream.