Lead analytical development and characterization activities for gene therapy and/or vaccines
Develop and optimize analytical methodologies for product characterization
Represent the analytical development group in cross-functional program teams and translate project goals into actionable plans
Manage and execute technology transfer of analytical methods from analytical development labs to GMP facilities (QC)
Identify and evaluate opportunities for analytical method innovation and improvement
Identify and/or optimize analytical processes/methods to improve robustness, execution time, throughput, and cost while maintaining data quality and integrity
Support implementation of novel analytical methods and processes
Lead successful execution and analysis of analytical development and characterization experiments
Prioritize work and leadership across multiple product 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 potency/biophysical assays 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.
Experience with analytical characterization of viral vectors, cell therapy, or biologics
Experience with cell line development
Experience with cell engineering (vectors, CRISPR)
Experience with NGS