23452-MS&T Scientist- Meath Contractor

This is an 11-month contract, an onsite lab-based role, and approximately 1x weekend shift per month required (days)

 Purpose

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 in Dunboyne.

• 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.

Responsibilties

• 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.

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.