MS&T Director Role
This is an exciting opportunity to lead the development of a Process Sciences Laboratory. As MS&T Associate Director, you will provide leadership and technical support, collaborating with cross-functional teams to deliver projects on schedule.
Job Description:
The successful candidate will oversee the management of a talented team of Manufacturing Science & Technology Scientists, inspiring them to reach their potential. They will also be responsible for providing proactive, technical oversight of biologics inline and pipeline products.
Key Responsibilities:
* Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments.
* Technical Lead for MS&T Process Sciences and the site.
* Provide 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.
* Oversight of product robustness trends observed in commercial operations and alignment with laboratory models.
* 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.
Requirements:
* A Master's degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
* 8+ years of directly related working knowledge in academia, pharmaceutical, or biotechnology companies – 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.