Senior Scientist

Alachua, FL
Jun 07, 2022
Required Education
Masters Degree/MBA
Position Type
Full time

Job Responsibilities

  • 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

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 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.

Preferred Experience

  • 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