Manufacturing Specialist – Biologics

Desired Skills: biologics,manufacturing,upstream

The role:

PE Global is currently recruiting for a Scientist –  Manufacturing Science and Technology  on behalf of a leading company based in Meath.

This is an initial 11-month contract role. This role is an onsite role

Job Purpose

This role is part of the Manufacturing Science and Technology (MS&T) hub at the state-of-the-art, single-use,multi-product facility

• 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, 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 analytical testing to support USP-DSP scale-down model establishments, satellite runs and investigation/improvement studies in the MS&T lab
• Plan and execute DSP laboratory studies (i.e. chromatography runs, filter assessments)
• Support the transfer of analytical methods into the MS&T laboratory.
• Provide specialist analytical support to the site and the network for non-routine analysis and troubleshooting.
• Experimental design, execution, data analysis and interpretation.
• 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 Six Sigma and Change Management tools in the Analytical Sciences group 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 analytical 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***