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Staff Scientist Process Development-CRB
Mayo Clinic - Jacksonville, FL
posted 2 months ago
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 blend of independent and collaborative work to enhance the quality and efficiency of therapeutic processes, ultimately aiming to deliver impactful treatments to patients. The role involves significant technical documentation, data analysis, and mentorship of junior staff, all within a cGMP compliant manufacturing 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 and protocols.
- Draft and review technical documentation to support clinical production and product validation for FDA-regulated operations.
- Provide direction and training to junior scientists and manufacturing personnel.
- Develop release test methods and mature research analytical methodologies into development and cGMP.
- Apply DOE/QBD principles to plan and perform experiments, analyze data, and generate presentations.
- 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 able to work independently 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.
Nice-to-haves
- Experience in development and characterization of cell therapy products, specifically CAR-T.
- Experience with assay development.
- Preference for candidates with experience in immune effector cell biomanufacturing.
Benefits
- Competitive compensation
- Comprehensive benefit plans
- Continuing education and advancement opportunities
