19832-Analytical Sciences Specialist-Dublin Contractor

This is an 11-month contract initially.

Purpose:

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. A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on time, holding self and team accountable for commitments, decisions, actions, and behaviors. S/he will also have excellent oral and written communication skills, with the ability to effectively articulate an understanding of process science, in order to drive decision-making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.

Responsibilities:

Reporting to the site Principal Analytical Scientist and based at the  Dublin site, the Associate Specialist, Analytical Sciences responsibilities include but are not limited to:

• Provide analytical support to the Process Sciences Team.
• Support the qualification of the new analytical science laboratory.
• Support the transfer of new analytical methods into the analytical sciences laboratory.
• Provide specialist analytical support to Quality Control for characterization 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 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/meetings.
• 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.

Requirements:

• 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 the company.
• 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.