The Manufacturing Science and Technology(MS&T) Team are a multidisciplinary science and engineering team that provide technical support to the site. The MS&T laboratory has a small scale model of the manufacturing process for process development, raw material screening and investigational support. The Analytical Sciences team within this laboratory, provide analytical support to this laboratory as well as technical and investigational support to the Quality Control Laboratory. They also lead Process Analytical Technologies activiites, the introduction of new technologies and manage analytical method lifecycle activities on site.
Reporting to the site Principal Analytical Scientist and based at the Biotech Dublin site, the Associate Specialist, Analytical Sciences responsibilities include, but are not limited to:
- Provide analytical support to the Process Sciences Team at Dublin.
- Support the qualification of the new analytical science laboratory at Dublin.
- Support the transfer of new analytical methods into the analytical sciences laboratory.
- Provide specialist analytical support to Quality Control for characterisation and non-routine analysis and troubleshooting.
- Experimental design, execution, data analysis and interpretation.
- Interpretation of trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting.
- Assuring effective application ofLeanSixSigma and Change Management tools in theAnalytical 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.
- Keep up to date with scientific and technical developments.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
This role requires an individual with a minimum of BSc with directly related analytical experience in academia, pharmaceutical or biotechnology company -with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
With a Bachelor's degree (or higher) in Analytical Sciences/Chemistry/Biological Science or related, the successful candidate will also show ambition and drive to develop and advance their career within MSD.
Preferred Experience and Skills:
- Knowledgeable in protein chemistry and analytical techniques (e.g. HPLC, GC, CE and protein biochemistry etc.), method validations, method transfers and equipment qualifications in a GMP environment.
- Knowledge of statistical methods for DOE design and data analysis.
- Knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.