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Senior Process Manager

1 month ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
Senior Process Manager - Life Sciences

This is a fantastic opportunity to be part of a fast-paced project, with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.

Responsibilities:
  • Support the design, construction and qualification of upstream & downstream equipment.
  • 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.
    • Supporting multidisciplinary teams for process improvement and troubleshooting with end-to-end product focus.
    • Applying Lean Six Sigma tools by:
      • Securing continuity of an appropriate LSS/CEM level of knowledge.
      • Facilitating problem solving & risk assessment (FMEA) projects/meetings.
      • Making problems visible and strive for continuous improvement.
    • Serving as a key member during internal audits and external inspections/audits
    • Lead and support various manufacturing science and technology organisational initiatives as needed
    • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer
    About You:
    • Directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practice.
    • Self-starter and results focused.
    • Excellent oral and written communication skills.
    • Bachelor's degree or higher in Biological Sciences/Chemical Engineering/Chemistry.
    • Proven track record in delivering excellence.
    • Experience with upstream cell culture and/or downstream purification of biological molecules.
    • Experience with tech transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
    • Working knowledge of statistical methods of DOE design and data analysis.