Lead process definition and implementation activities for gene therapy and/or vaccines
Develop and optimize production and process methodologies
Represent the process development group in cross-functional program teams and translate project goals into actionable plans
Manage and execute technology transfer of production processes from development labs to GMP facilities
Identify and evaluate opportunities for process innovation and improvement for scaling up and scaling out processes
Identify and/or optimize unit operations to improve robustness, cycle time, throughput, and cost while maintaining product quality
Support implementation of novel process solutions
Lead successful execution and analysis of process development and characterization experiments
Prioritize work and leadership across multiple process development and manufacturing programs
Interface directly with customers to evaluate requirements and identify opportunities within development programs.
Collaborate with peer groups in other Franchises to develop best practices.
Communicating technical information to internal and external partners.
Writing and reviewing technical documents and regulatory submissions
PhD and a minimum of 3 years experience or MS and a minimum of 6 years experience in vaccines and/or gene therapy process development
Strong scientific background with extensive hands-on experience in a broad array of biochemical/biophysical techniques is required.
Extensive experience with experimental design, data analysis, organization and presentation of complex scientific data.
The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
Ability to lead, manage, and motivate a diverse team across various functions.
Demonstrated ability to work efficiently across multiple project teams and business functions.
Hands-on experience with viral vector (preferred), cell therapy, or biologics manufacturing
Experience with cell line development
Experience with cell engineering (vectors, CRISPR)
Experience with NGS