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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Senior Specialist MS&T


Reference: SMC25978 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing and Technology Manager

The Senior Specialist MS&T (DS Process Science) delivers a range of technical support to the Drug Substance Business: supporting technical investigations within the Integrated Process Team, supporting significant projects in the MS&T laboratory, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.

Duties and Responsibilities:

  • Leading, designing, supporting and executing experimental design, data analysis and interpretation to resolve complex deviations.
  • Leading process improvement and troubleshooting with end-to-end product focus. Assist in, and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs.
  • Executing experimental design, data analysis and interpretation
  • Supporting the process sciences team during small scale model run execution, including buffer preparation, equipment set up, run execution, sampling and data analysis.
  • Author and review standard operating procedures (SOPs), protocols and reports as required.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
Education and Experience:
  • A Master’s degree in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering with 2+ years’ experience or a Bachelor’s degree in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering with 4+ years’ experience.
  • Experience leading technical related projects.
Key Skills and Competencies Required:
  • Demonstrated leadership and proven track record of delivering projects of technical complexity
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Desirable evidence of continuous professional development.
  • Experience in drug substance process development, process characterisation studies, downstream technology, and/or process modeling.
  • Experience in designing and executing experimental programs in the laboratory. Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
  • Technical experience in the drug substance manufacture of biological molecules at the lab, pilot and/or commercial-scale.
  • Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
  • Technical writing skills.
  • Demonstrated leadership and change management skills with a continuous improvement focus
  • Proven track record of delivering high performance through development and coaching of a team.
  • Evidence of continuous professional development.
  • Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
  • Desire to continuously learn, improve and develop.
If interested in this posting please feel free to contact Sean McCarthy at [email protected]for further information.