Senior Staff Scientist

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 
• Lead the 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, coordinate, and approve technical documentation such as batch documentation, laboratory notebooks, protocols, and reports
• Draft, review, and approve 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
• Guides the development of 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. 
• Oversee project transition to clinical manufacturing and ensure alignment with regulatory requirements.
• Active participation in BOM and COG creation leading to budgetary forecasting.
• 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

Qualifications:

• PhD (8+ years of relevant industry experience) in chemical/biochemical engineering, biomedical engineering, immunology, cell/molecular biology, or other related science from an accredited institution.
• Deep experience in CAR-T cell therapy and similar cell therapy products, bioprocessing, process development, immunology, and/or cancer biology
• Experience in leading the development and characterization of cell therapy products, specifically CAR-T
• Self-motivated, highly organized, efficient, and able to work independently exercising strong decision-making skills
• Excellent written and verbal communication skills with ability to convey information across diverse audiences and stakeholders is 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

Why Mayo Clinic
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.