Senior Director of Process Development & Manufacturing
School of Medicine, Stanford, California, United States

Schedule: Full-time
Job Code: 4988
Employee Status: Regular
Grade: N
Requisition ID: 90601

The Laboratory for Cell and Gene Medicine and Center for Definitive and Curative Medicine at Stanford University are seeking a Director of Process Development and Manufacturing (Research Technical Manager 3) to provide strategic leadership on translational research that brings cell and gene therapy products from the bench to the bedside. Specifically, advises on the best strategy to translate the scientific discovery from a research lab to a clinical grade lab, and on the best approach to develop and manufacture the drug according to Good Manufacturing Practice (cGMP) and the highest regulatory standards. Instrumental in implementing strategic vision for the LCGM to develop multiple technology platforms (including T cells, gene editing, pluripotent stem cells and vectors) to the benefit of several Stanford faculty and research programs. The Director of PDM will exercise delegated authority for policy and programmatic decisions and achieve goals through technical and managerial staff engaged in developing, advancing and applying science, engineering and technology.

Duties include:

• Provide strategic direction for the LCGM and CDCM; create strategic plans for considerable complexity and scope; set long-range direction and make high-level decisions; propose and manage the implementation of significant programmatic changes; establish policies as needed.
• Direct and oversee the overall scientific, engineering or technical research function of the LCGM and CDCM. Collaborate with senior management, faculty and others in order to develop, communicate and manage a central strategic plan aligned with goals of the larger organization and consistent with the university's overall mission.
• Identify, clarify, and resolve highly complex issues with university/school-wide impact and substantial significance, which span multiple areas, requiring broad discretion and judgment.
• Responsible for ensuring that state-of-the-art scientific, engineering or technical research is adequately funded, staffed, equipped, and housed.
• Accountable for ensuring finance, budget, personnel, and facilities resources are used appropriately.
• Manage the adoption and adaptation of emerging technologies to meet changing requirements, capabilities, and opportunities.
• Lead high-level scientific, engineering, or technical research programs and initiatives through technical design, development, integration and outreach.
• Advise university/school-wide senior management on technical futures.
• Collaborate with university leaders on scientific, engineering or technical research project decisions.

* - Other duties may also be assigned

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.


To be considered for this position please visit our web site and apply on line at the following link: https://apptrkr.com/2766978

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.







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