MS&T Bioprocess Scientist (Specialist)
This is a specialist role part of the Manufacturing Science and Technology (MS&T) hub at our state-of-the-art, single-use,multi-product facility. The MS&T Scientist 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.
Main 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 Six Sigma and Change Management tools in the Analytical Sciences group by:
o Securing continuity of an appropriate level of knowledge
o Facilitating problem solving & risk assessment (FMEA) projects/meeting
o Making problems visible and striving for continuous improvement
o Serving as an analytical specialist during internal audits and external inspections/audits
o Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners
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