23012-Associate Director Manager MS&T Lab-Dublin Contractor

Purpose:

The MS&T Associate Director, Bioprocess lead 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.

Responsibilities:

• 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 the 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.

Requirements:

• 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.