Bioprocess Lead

2 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

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Bioprocess Lead - Associate Director, DublinClient:

Next Generation

Location:

Dublin, Ireland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

c3bd557ee822

Job Views:

2

Posted:

29.03.2025

Expiry Date:

13.05.2025

Job Description:

A fantastic opportunity has arisen for an Associate Director, Bioprocess Lead in MS&T

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 delivery of new products for commercial operations.

What you will do:

Bring energy, knowledge, and innovation to carry out 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.
  • 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:

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.
  • The successful candidate will also have demonstrated the 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, design of studies in a multi-disciplinary team environment.
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