MS&T Spsecialist – Upstream
1 Weekend Shift per month
An opportunity for a Manufacturing Science and Technology (MS&T) Specialist has arisen in a state-of-the-art Biologics facility in West Dublin.
The successful candidate will be responsible for contributing to the overall running of the MS&T Bioprocess Laboratory including the planning and execution of scale-down model establishment in upstream/downstream, analytical testing, satellite and improvement studies
Responsibilities:
* Plan and execute upstream activities (USP) for scale-down model establishments, satellite runs and investigation/improvement studies in the MS&T lab (i.e. vial thaws, shake flask passaging, benchtop bioreactor operations including inoculation, sampling, feeding and harvest)
* Support the transfer of new products (NPI) into the MS&T laboratory.
* Provide upstream specialist support to the site and the network for non-routine analysis and troubleshooting.
* Experimental design, execution, data analysis and interpretation through DOEs.
* Author and review standard operating procedures and technical reports
* Supporting multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
* Assuring effective application of Lean SixSigma and Change Management tools in the MS&T lab team by:
* Making problems visible and striving for continuous improvement.
* Serving as an upstream specialist during internal audits and external inspections/audits.
* Complete product robustness monitoring in partnership with global technical teams and provide leadership for investigations.
Qualifications and Experience
* Bachelor of Science degree qualification with minimum 5 years of experience, Master of Science degree qualification with minimum of 3 years experience.
* Technical expertise with biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
* Proven ability to work as part of a team but also on own initiative as well.
* Ability to think logically and be proactive under pressure.
* Effective communicator and deep technical expertise in science.
* Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
* Experience working in a GMP / regulated environment is desirable.
* Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution
For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)