Associate Director, Process Development and Manufacturing
The Associate Director of Process Development and Manufacturing (AD-PDM; RTM1) provides programmatic guidance, oversight and administration for the development of all hematopoietic cellular 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. The Associate 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 Associate 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 strategic planning for own work group; participate with senior managers in higher level strategic planning. Communicate operational objectives and assignments and delegate to staff.
- Manage the daily operations of an assigned area(s) which include recruiting, hiring, training, developing evaluating and setting priorities of staff, coordinate business, technical, and educational activities for direct reports.
- Oversee interdepartmental activities, projects and efforts by applying advanced technical and professional knowledge. Serve as the initial managerial escalation point for problems from clients and other staff.
- Manage project budgets, schedules, and resources. Oversee preparation of periodic financial and technical reports and operating plans.
- Interface with clients to determine project requirements. Establish service level agreements with clients.
- Monitor scientific, engineering, and/or technology trends and evaluate emerging technologies to recommend for adoption and implementation.
- 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.
- Communicate and implement policies, procedures, best practices, recommendations and guidelines compliance with established University administrative policies and procedures.
* - Other duties may also be assigned
- 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.
- 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.
May require extended hours, evenings and weekends.
- Schedule: Full-time
- Job Code: 4986
- Employee Status: Regular
- Grade: L
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 86844