Director, Manufacturing Science and Technology, Process Engineering

We are looking for an experienced leader to lead our cell therapy Manufacturing Science and Technology (MS&T) team. The Director, Manufacturing Science and Technology, Process Engineering, will oversee and ensure rapid commercialization of robust, compliant and cost-effective cell therapy manufacturing processes working with Late-Stage Process Development, site Manufacturing Science and Technology (MS&T) and Manufacturing Operations teams.   

The Director will be responsible for the technical oversight of cell therapy manufacturing processes from at-scale process validation through commercialization and life cycle management of cell therapy products manufactured at internal and external sites. This is a leadership position responsible for developing and managing a team of engineers. You will help ensure that our cell therapy manufacturing processes are tech transferred for clinical and commercial manufacture, validated and commercialized successfully.  

We are looking for an experienced people manager with expertise in tech transfer, site readiness for clinical and PPQ manufacture, process validation and commercialization activities. This position will report to Executive Director, Process Engineering, Cell Therapy Development and Operations, and is located in Gaithersburg, MD. 

Role Accountabilities 

• Lead the commercial manufacturing process tech transfer, process validation and market approval for the cell therapy assets 

• Collaborate with Late-Stage Process Development, site MS&T, Manufacturing Ops, Quality and Regulatory teams to support product development, tech transfer, and life-cycle management 

• Develop and implement robust and site-agnostic tech transfer, process control and process validation strategies to enable clinical and commercial manufacture of cell therapy products 

• Develop and implement proactive process analysis strategy to monitor the process performance and oversee process improvement initiatives 

• Develop technical standards and templates for the process validation and market approval workflow including, authoring of validation master plan, validation protocols, validation reports and manufacturing campaign summary reports 

• Ensure all MS&T activities adhere to the internal quality standards and comply with global regulatory standards for the cell therapy products 

• Provide technical expertise and leadership to drive the implementation of process improvements to enable reduction in COGs, increase throughput, facility capacity and quality compliance 

• Champion the ad