Purpose
This role is part of the Manufacturing Science and Technology (MS&T) hub
The MS&T Scientist (Specialist) is responsible for contributing to the overall running of the MS&T Bioprocess Laboratory. 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/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.
Experience
* 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.
This role is a site and lab-based role.