Associate Director

2 weeks ago

Dublin, Dublin City, Ireland eTeam Full time
Associate Director, Bioprocess Lead in MS&T
  • Location: Swords
  • Type of contract: Fixed Term Contract for 11 months
  • Work model: Hybrid model potentially 2 days remote working
  • Our client: A global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
SUMMARY
The MS&T Associate Director, 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 the delivery of new products for commercial operations.

WHAT YOU WILL DO
Reporting to the Manufacturing Science & Technology Laboratory Lead, the responsibilities include, but are not limited to the following:
  • 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.
  • 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.
  • Oversee 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, and 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
To excel in this role, you will more than likely have:
  • 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.
  • Demonstrated ability to deliver projects and programs, with a strong understanding of lean and laboratory operations.
  • Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science to drive decision making, impact assessments, and design of studies in a multi-disciplinary team environment.
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