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, compliantand 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 externalsites. 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 withexpertise intech 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 inGaithersburg, 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 Regulatoryteams to support product development, techtransfer, 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 tomonitor the process performance and oversee process improvement initiatives

• Developtechnical standards and templates for the process validation and market approvalworkflow 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 expertiseand leadership to drive the implementation of process improvements to enable reduction in COGs, increase throughput, facility capacity and quality compliance

• Champion the adoption of the latest technologies and automationadvancements in the cell therapy manufacturingto enhance manufacturing efficiencyand product quality

• Author and review process validation and commercial manufacturing process related CTD content for the market approval

• Maintaina collaborative, engineering-focused, innovativeand continuous improvementculture within the Process Engineering team

Education, Qualifications, Skills and Experience

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related field, or a Master’s degree with relevant industry experience

• 8+ years of experience inbiologics/cell/gene therapy manufacturing science, tech transfer or late-stage process development, with 4+ years in a leadership role within the biotechnology or biopharmaceutical industry

• Demonstrated ability to design and execute process validationstrategies and relevant technical documentation to deliver successful PPQ and support commercial manufacture

• Demonstrated ability to manage process monitoring and post-approval process improvement activities

• Proven recordof managing and leading a team of engineers with preferred expertise in CAR-T and/or human stem cell therapies

• Ability to author process validation and commercial manufacturing process related content for the market approval