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DESIRED QUALIFICATIONS:
• Advanced degree in biology or other related field.
• Knowledge of: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirements.
• Experience with cGMP manufacturing of Phase I/II clinical products.
• Experience with development of cGMP compliant manufacturing and analytical processes for cell and gene therapies.
• Extensive experience in cellular immunology, stem cell biology, cellular therapies, current practices of blood cell transplantation.
• At least 5 years of management experience including hiring, supervising, appraising employees. Matrix management experience desirable.
• Experienced 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 software as Microsoft Office, Access, Excel, Word, Statistical analysis software (Graph Pad Prism, SAS, etc), Flow Cytometry, Bioreactor control and analytical packages.
• Bioreactors, cell counter, magnetic selection devices, discreet particle counter, centrifuges, microscopes, pH meter, Flow cytometer, biosafety cabinet, plate readers.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of relevant experience, or combination of education and relevant experience. Advanced degree may be required.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• Experience leading or overseeing the work of technical staff.
• Understanding of relevant scientific, engineering, or technical disciplines.
• Ability to problem solve.
• Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
• Experience leading scientific, engineering, or technical research projects or programs.
• Knowledge of emerging technologies, trends, methodologies, and resource management principles.
• Ability to work and communicate effectively with others.
• Strong customer relationship and consensus building skills.
• Ability to influence and establish effective working relationships in a diverse environment.
• Ability to resolve issues quickly and make decisions that meet university objectives in a collaborative culture.
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: (remove if none)
WORKING CONDITIONS:
May require extended hours, evenings and weekends.