
Science Leader
2 days ago
MS&T Associate Director
This is a prime opportunity to assume a leading role in the pharmaceutical industry. As an Associate Director, you will play a pivotal part in supporting the development of our site and providing leadership in Drug Substance technical support.
Duties:
- Lead a team of Manufacturing Science & Technology Scientists in delivering new products for commercial operations.
- Provide proactive technical oversight of biologics inline and pipeline products.
- Conduct technical assessments for process investigations, risk assessments, and evaluation of specifications and material qualification.
- Cultivate a team on development and execution of technical studies, continuous improvement of existing biologics processes, and new product launch.
- Oversight of product robustness trends observed in commercial operations and alignment with laboratory models.
- Implement digital tools at Biotech Dublin facility.
- Support regulatory authoring and review of technical documentation, technical report writing, and global regulatory submissions.
- Participate in creation of the laboratory budget and review actual performance against forecast.
Requirements:
- Master's degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
- 8+ years of working experience in academia, pharmaceutical, or biotechnology company, along with familiarity of current regulatory requirements and Good Manufacturing Practices.
- Able to deliver projects and programs, with a strong understanding of lean and laboratory operations.
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