Senior Scientist

Job Responsibilities

• 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

Minimum Requirements

• 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.

Preferred Experience

• 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