Join the Center for Regenerative Biotherapeutics at Mayo Clinic! 

Mayo is seeking a candidate to continue to build out our process development team in Jacksonville, FL where you will have the opportunity to drive new and various therapies to clinic alongside some of the best medical personnel in the country. We are seeking candidates with proven ability to successfully work independently and collaboratively across functions to enhance quality, quantity, efficiency, and fuel breakthroughs that can deliver needed therapies to the patients that need them and make an impact on people’s lives.

Responsibilities:

More specifically, we are looking for a scientist that can lead the development, scale-up and optimization of novel/new biotherapeutics in preparation for cGMP compliant manufacturing operations including cell therapy CAR-T drug products.

• Develop, optimize, and execute various cell therapy processes including cell culture, cell selection, activation, expansion, and harvest 
• Design and execution of studies to support process optimization for clinical translation of novel biotherapeutics
• Optimize process steps to target process scale for improvement of existing methods or implementation of novel technology 
• Analysis, organization, and presentation of data in a clear and concise manner
• 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
• Provides direction and training to junior scientists and manufacturing personnel 
• Exceptional interpersonal and communication skills, effective, efficient, and organized, familiarity with 5S methodology a plus
• Develop release test methods, maturation of research analytical methodology into development and cGMP, analytical method technology transfer to and from our facilities and/or contract vendors. 
• Apply DOE/QBD principals to plan and perform experiments, analyze data, and generate presentations for communication to working group and department wide
• Familiarity of analytical methods and experience in statistical analysis using JMP preferred

Education/Experience Required: 

• PhD (5+ years of relevant industry experience) in chemical/biochemical engineering, biomedical engineering, immunology, cell/molecular biology, or other related science from an accredited institution.
• Experience in CAR-T cell therapy and similar cell therapy products, bioprocessing, process development, immunology, and/or cancer biology preferred 
• Experience in development and characterization of cell therapy products, specifically CAR-T preferred
• Self-motivated, highly organized, efficient, and able to work independently exercising strong decision-making skills
• Excellent written and verbal communication skills are necessary. 
• Capable of reproducing a reference method using available procedures without supervision
• Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures. 
• Experience with data collection, organization, analysis and delivery of information
• Experience with assay development highly desired
• Preference given to candidates with experience in immune effector cell biomanufacturing

Please note that visa sponsorship is not available for this position.  Mayo Clinic does not participate in OPT Stem extensions.