Staff Scientist Process Development-CRB

$97,531 - $146,453/Yr

Mayo Clinic - Jacksonville, FL

Full-time - Senior

Jacksonville, FL

Hospitals

About the position

The Staff Scientist in Process Development at Mayo Clinic will play a crucial role in the Center for Regenerative Biotherapeutics, focusing on the development, scale-up, and optimization of novel biotherapeutics, particularly in the area of CAR-T cell therapy. This position requires a strong background in scientific research and process development, with an emphasis on collaboration and innovation to enhance therapeutic delivery to patients. The role involves both independent and team-based work, contributing to the advancement of clinical therapies in a cGMP compliant environment.

Responsibilities

• Lead the development, scale-up, and optimization of novel biotherapeutics for cGMP compliant manufacturing operations.
• Develop, optimize, and execute various cell therapy processes including cell culture, selection, activation, expansion, and harvest.
• Design and execute studies to support process optimization for clinical translation of novel biotherapeutics.
• Optimize process steps to improve existing methods or implement novel technology.
• Analyze, organize, and present data clearly and concisely.
• Author, review, and coordinate technical documentation such as batch documentation, laboratory notebooks, protocols, and reports.
• Draft and review technical documentation to support clinical production and product validation for FDA-regulated, cGMP compliant manufacturing operations.
• Provide direction and training to junior scientists and manufacturing personnel.
• Develop release test methods and mature research analytical methodology into development and cGMP.
• Apply DOE/QBD principles to plan and perform experiments, analyze data, and generate presentations for communication.
• Familiarity with analytical methods and experience in statistical analysis using JMP.

Requirements

• PhD in chemical/biochemical engineering, biomedical engineering, immunology, cell/molecular biology, or related science with 5+ years of relevant industry experience.
• Experience in CAR-T cell therapy and similar cell therapy products, bioprocessing, and process development.
• Self-motivated, highly organized, and efficient with strong decision-making skills.
• Excellent written and verbal communication skills.
• Demonstrated analytical and scientific competency with process development and/or validation of lab techniques.
• Experience with data collection, organization, analysis, and delivery of information.
• Experience with assay development is highly desired.

Nice-to-haves

• Familiarity with 5S methodology.
• Experience in development and characterization of cell therapy products, specifically CAR-T.
• Preference for candidates with experience in immune effector cell biomanufacturing.

Benefits

• Opportunities for advancement
• Competitive compensation
• Comprehensive benefit plans
• Continuing education support