Director of Process Development and Manufacturing - 72560
The Director of Process Development and Manufacturing provides programmatic guidance, oversight and administration for the development of all cell and gene therapy protocols conducted by or in collaboration with the medical and research faculty of the Stanford School of Medicine under Investigational New Drug (IND) applications. Cellular therapies include all ex-vivo manipulations of patient samples such as genetic modification, expansion, differentiation, formulation or device selection. Cell populations typically include T cells, dendritic cells, hematopoietic stem cells and derivatives thereof intended for infusion. Other products include skin grafts, cardiomyocytes and neural stem or progenitor cells. Gene Therapies will include (but are not limited to) clinical scale production of AAV and Lentiviral vectors and genetic modification of the cell types described above with either viral vectors or specific endonucleases. The Director will act as a collaborative research investigator at all stages of research and product development to ensure the creation of protocols and processes that incorporate contemporary technologies and methodologies and provide products that are consistent with scientific and clinical goals of the program. S/He will be responsible for the subsequent creation of an integrated process to transfer technology from the research and development programs to the manufacturing facility. The Director will also be responsible for the development and administration of comprehensive operating plans and budgets contributing to the achievement of programmatic and institutional goals.
Provide strategy, vision, and direction; make decisions that establish objectives for the overall direction or operation of a significant project or area.
Identify, clarify, and resolve issues with strategic impact and substantial significance, which may span multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
Develop policies and procedures as they relate to academic or program activities.
Implement and maintain quality control standards, and evaluate program effectiveness.
Oversee budget and schedule for large programs and/or multiple projects.
Negotiate with internal departments and external agencies with authority to commit resources and effort.
Recommend the adoption of emerging technologies and the development of new methods and approaches.
Liaise with senior management and cross functional areas and schools. Serve as a liaison to external organizations.
Supervise other staff, including hiring, performance management, and related duties, in addition to providing instruction on complex techniques and direction on projects.
* - Other duties may also be assigned
Qualifications 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.
Microsoft Office, Access, Excel, Windows NT, Word and miscellaneous device control software
Statistical analysis software (Graph Pad Prism, SAS, etc)
Flow Cytometry, Chromatography, Biorector control and analytical packages.
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):
Advance degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required in some areas.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated experience leading and managing a large organization of technical staff through subordinate managers.
Demonstrated experience leading large, complex projects or programs.
Demonstrated ability to work and communicate effectively with others.
CERTIFICATIONS & LICENSES:
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.
Location: School of Medicine
Job Code: 4988