Manager of Manufacturing Science and Technology

2 weeks ago


Dublin, Dublin City, Ireland Recruitment by Aphex Group Full time

Job Description:

We are seeking a highly skilled Manager of Manufacturing Science and Technology to join our team at Recruitment by Aphex Group.

About the Role:

  • Lead technical assessments for process investigations, risk assessments, evaluation of specifications, and material qualification.
  • Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments.
  • Develop and execute technical studies, continuous improvement of existing biologics processes, and new product launch.
  • Complete experimental design, execution, data analysis, and interpretation for improvement programs.

Responsibilities:

  • Oversee the product robustness trends observed in commercial operations and alignment with laboratory models.
  • Leverage digital tools to deliver business value through predictive/proactive issue resolution and rapid investigation closure.
  • Assist in the regulatory authoring and review of technical documentation and global regulatory submissions.

Requirements:

  • Masters degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
  • 8+ years directly related working knowledge in academia, pharmaceutical, or biotechnology company.
  • Familiarity with current regulatory requirements and 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.


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