Director, Process Development and Manufacturing

DESIRED QUALIFICATIONS:

• PhD in microbiology, biological sciences, etc with an emphasis on cell and gene therapy.
• Experience with TCR, T cells, HSCs, iPSC, gene editing, and/or cell and gene therapy process development/manufacturing desired.
• Experience with large scale/high throughput clinical cell manufacturing or gene-editing platforms a plus.
• Knowledge of and experience generating SOPs, batch records, and other documentation for tech transfer into cGMP preferred.
• Experience in GMP manufacturing setting, technology transfer (e.g., from academic institutions or to a third-party contract manufacturing organization (CMO) and implementation of new technologies in a regulated environment (e.g., GMP, GLP, GxP)
• Experience with following assays required/preferred: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR
• Experience with the following software preferred: Prism/GraphPad, FlowJo/Cytobank, Microsoft Word/Excel/Powerpoint, SnapGene, a plus: DOE software/JMP
• Extensive experience in cellular immunology, stem cell biology, cellular therapies, and molecular biology.
• Experience in the culture and expansion of human blood cells, mechanical isolation and analysis of cell populations, bioreactor-based growth of human blood cells, cytokine biology, molecular biology, tissue engineering.
• Experience with bioreactors, FPLC, cell counter, magnetic selection devices, discreet particle counter, centrifuges, microscopes, pH meter, Flow cytometer, biosafety cabinet, plate readers, ultrafiltration devices.                     

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Experience leading, managing, motivating and developing technical staff.
• Experience leading complex scientific, engineering or technical research projects or programs.
• Detailed understanding of relevant business and technical knowledge and problem resolution.
• Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
• Knowledge of emerging technologies, trends, methodologies, and resource management principles.
• Demonstrated ability to work and communicate effectively with others.
• Exceptional customer relationship and consensus building skills.
• Ability to influence and establish effective working relationships in a diverse environment.
• Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.
• Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirements

CERTIFICATIONS & LICENSES:

None

PHYSICAL REQUIREMENTS*:

• Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
• Occasionally sit, use a telephone or write by hand.
• Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Additional PHYSICAL REQUIREMENTS:

WORKING CONDITIONS:

May require extended hours, evenings and weekends.