Associate Director, Palo Alto, CA
Process Development and Manufacturing
The Associate Director of Process Development and Manufacturing provides programmatic guidance, oversight and administration for the development of all hematopoietic cellular therapy protocols. 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.
May require extended hours, evenings and weekends.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website