Process Development Specialist

3 days ago


Co Meath, Ireland Recruitment By Aphex Group Full time
About the Position

We are seeking a highly skilled Drug Substance Professional to join our team at Recruitment By Aphex Group. This is an 11-month initial contract opportunity.

Job Summary:

The Drug Substance Professional will contribute to the overall running of the MS&T Bioprocess Laboratory, working closely with a diverse and interdisciplinary team to build capability and knowledge in the manufacture of biologics.

Key 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 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 securing continuity of an appropriate level of knowledge.
  • Facilitating problem-solving & risk assessment (FMEA) projects/meetings 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.


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