Biotechnology Process Lead

6 days ago


Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

At Quanta Consultancy Services Ltd, we are seeking a highly skilled Biotechnology Process Lead to join our team in Dublin. As a key member of our Life Sciences department, you will be responsible for supporting the design, construction and qualification of upstream & downstream equipment.

About the Role

The ideal candidate will have directly related experience in academia, pharmaceutical or biotechnology company, along with a working knowledge of current regulatory requirements and current Good Manufacturing Practice.

You will work closely with multidisciplinary teams to support establishment of the commercial process and routine manufacturing by:

  • Supporting experimental design, execution, data analysis and interpretation.
  • Interpreting 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 deviation management.
  • Supporting change control prioritisation and implementation.
  • Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.

We are looking for a self-starter and results-focused individual with excellent oral and written communication skills. A Bachelor's degree or higher in Biological Sciences/Chemical Engineering/Chemistry is required, along with a proven track record in delivering excellence.



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