Associate Director for Process Development and Manufacturing

Company: Stanford University School of Medicine
Location: Palo Alto
Posted on: June 22, 2022

Job Description:

Stanford University is seeking a Associate Director for Process Development and Manufacturing in the Stanford's Center for Cancer Cell Therapy GMP Facility (Research Technical Manager 1). This role will involve management and coordination of administrative and operations related functions for assigned research area(s) engaged in developing, advancing and applying sciences, engineering and technical research to innovate and deliver solutions in support of organizational goals. Also to include managing staff at least 50% of the time to achieve the research and teaching mission, goals and objectives of the unit, and partnering with faculty leadership on departmental affairs.
The position will be located at the Laboratory for Cell and Gene Medicine (LCGM), a purpose-build cGMP facility at Stanford School of Medicine that supports cellular therapy process development and manufacturing across diverse clinical specialties.
Learn more about our team here: https://med.stanford.edu/lcgm.html.
Duties include:

• 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.
• Communicate and implement policies, procedures, best practices, recommendations and guidelines compliance with established University administrative policies and procedures.* - Other duties may also be assigned
  DESIRED QUALIFICATIONS:Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirementsExtensive experience in cellular immunology, stem cell biology, cellular therapies, and molecular biology.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.
  Software:
  • 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.
    Machines/Equip: Req./Pref
    • 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 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.
        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.
          WORKING CONDITIONS:May require extended hours, evenings and weekends.
          WORK STANDARDS:
          • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
          • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
          • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
            As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy

Keywords: Stanford University School of Medicine, Palo Alto , Associate Director for Process Development and Manufacturing, Executive , Palo Alto, California