Senior Director of Process Development & Manufacturing

DESIRED QUALIFICATIONS:

• Knowledge of: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirements
• 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, viral vector production and purification.
• Preferred field of expertise: Cellular Immunology, Gene Therapy.
• Preferred software expertise: Microsoft Office, Access, Excel, Windows NT, Word and miscellaneous device control software.
• Preferred statistical analysis software expertise (Graph Pad Prism, SAS, etc.).
• Knowledge of Flow Cytometry, Chromatography, Bioreactor control and analytical packages.
• Preferred Machines/Equip Knowledge: 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 ten years of relevant experience or combination of education and relevant experience. Advanced degree may be required in some areas.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Extensive experience leading and managing a large organization or technical staff through subordinate managers.
• Demonstrated experience leading large, complex scientific, engineering or technical research projects or programs.
• In-depth understanding of relevant business and technical disciplines.
• In-depth knowledge of emerging technologies, trends, methodologies, and resource management principles.
• Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
• Demonstrated ability to work and communicate effectively with others.
• Demonstrated ability to think strategically and deliver results.
• Exceptional customer relationship and consensus building skills.
• Ability to influence and establish effective working relationships in a diverse environment.  Motivate and mentor staff.
• Resolve complex 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.