Lead Process Engineer

4 days ago


Dublin, Dublin City, Ireland RT Full time

Excellent opportunity for a Lead Bioprocess Engineer to work in a Global Multi-national Biopharmaceutical plant in Dublin.

This initial contract role will suit a Senior/Lead Bioprocess Engineer/Team Leader and will lead and manage the MS&T team for the Dublin Biotech site.

Bioprocess lead at Biotech Dublin supports the development of the site, providing leadership and Drug Substance technical support, in the Process Sciences Laboratory. Leads/participates in cross functional teams to deliver all project and investigational activities on schedule.

The successful candidate will develop a talented team of Manufacturing Science & Technology Scientists in delivery of new products for commercial operations.

Role:
  • Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments. Inspire, reward and develop individuals, helping them to reach their potential.
  • Technical Lead for MS&T Process Sciences and the site.
  • To provide proactive, technical oversight of the biologics inline & pipeline products.
  • Lead technical assessments for process investigations, risk assessments, evaluation of specifications and material qualification.
  • Coach the team on development and execution of technical studies, continuous improvement of existing biologics processes and for new product launch.
  • Complete experimental design, execution, data analysis and interpretation for improvement programs.
  • Oversight of the product robustness trends observed in commercial operations and alignment with laboratory models, such as SIMCA for multivariate data analyses.
  • Lead and/or support deployment and use of various digital tools at Biotech Dublin facility: Leverage these tools to deliver business value through predictive/proactive issue resolution, rapid investigation closure, improved yield/throughput.
  • Assist in the regulatory authoring and review of technical documentation, technical report writing and global regulatory submissions.
  • Support creation of the laboratory budget and review actual performance against forecast.
What skills you will need:
  • Ideally a Master's in Biological Sciences/ Chemical Engineering/ Biological Engineering/Chemistry.
  • 8+ years directly related working knowledge in academia, pharmaceutical or biotechnology company – along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices.
  • The successful candidate will also have demonstrated the ability to deliver projects and programs, with a strong understanding of lean and laboratory operations.
Seniority level

Mid-Senior level

Employment type

Contract

Job function

Science and Manufacturing

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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