Orion Group Life Sciences are currently recruiting an MSAT Scientist on behalf of our Multinational Biopharmaceutical Client based in Meath on an initial 11-Month contract with potential to extend.
This role is part of the Manufacturing Science and Technology (MS&T) hub at our state-of-the-art, single-use, multi-product facility in Dunboyne.
* The MS&T Scientist (Specialist) is responsible for contributing to the overall running of the MS&T Bioprocess Laboratory and working across site as part of a diverse and interdisciplinary team to build capability and knowledge in the manufacture of biologics.
* Key responsibilities of the MS&T Scientist include the planning and execution of scale-down model establishment in upstream/downstream, analytical testing, satellite and improvement studies in the MS&T Bioprocess Lab, and the provision of technical expertise and leadership to support successful new product introduction.
What you will do:
* 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:
* Securing continuity of an appropriate level of knowledge.
* Facilitating problem solving & risk assessment (FMEA) projects/meeting.
* Making problems visible and striving for continuous improvement.
* Serving as an upstream specialist during internal audits and external inspections/audits.
* Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
* Ability to lead and coach others to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
* Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to represent MS&T on global and interdisciplinary teams.
* Complete product robustness monitoring in partnership with global technical teams and provide leadership for investigations.
* Demonstrate “safety first, quality always” mindset in all responsibilities.
Educational and experience requirements
* Bachelor of Science degree qualification with minimum 5 years of experience, Master of Science degree qualification with minimum of 3 years’ experience, or PhD degree qualification (scientific discipline in biotechnology, biochemistry, pharmacy, process engineering or equivalent).
* 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.
Other Job Requirements
* This role is a site and lab-based role.
* Approximately 1x weekend shift per month required (days)
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