Senior Scientist

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

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