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.