This is an 11-month initial contract.

Purpose

The MS&T Scientist (Specialist) is responsible for contributing to the overall running of the MS&T Bioprocess Laboratory and working across the 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.

Responsibilities

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 SixSigma 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/meetings
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.

Qualifications

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.