The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is seeking a Manufacturing Supervisor to provide highly specialized technical research, support and expert consultation including identifying, innovating and designing solutions for unique process development and manufacturing activities related to clinical materials manufacturing. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with clinical trial investigational Oral Immunotherapies. Duties include:
Independently implement, administer and evaluate day-to-day activities of the unit, function or program by identifying and executing tasks and objectives, making recommendations that impact policies and programs, and assigning resources to achieve the goals of the program.
Collect and analyze data, create reports, review and explain trends; formulate and evaluate alternative solutions and/or recommendations to achieve the goals of the program or function.
Analyze and interpret policies; develop, revise and implement procedures for program or function
Represent the program or function as the key contact and subject matter expert within the department, unit or school. Commit resources and provide information and/or training. May also represent the program or function to external/internal stakeholders and constituencies.
Organize and/or participate in outreach activities that may include developing communications and training, planning/promoting events and/or conferences.
May participate in development of budgets, monitor, and approve expenditures. May perform limited forecasting and provide recommendations that determine the budget.
May direct staff to perform various tasks and assignments. May also supervise staff.
* - Other duties may also be assigned DESIRED QUALIFICATIONS:
Bachelor or advanced degree in Nutrition or Biochemistry + 4 years related experience or combination of education and relevant experience.
2 years of experience in the following:
GMP Product Development
GMP Batch Development and Quality Assurance Documentation
Corrective and Preventive Action (CAPA) Risk Assessment
Multi- project Management
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated ability to prioritize own work and multi-task.
Demonstrated excellent organizational skills.
Demonstrated ability to take initiative and ownership of projects.
Ability to communicate effectively both orally and in writing.
Ability to routinely and independently exercise sound judgment in making decisions.
Demonstrated experience working independently and as part of a team.
Relevant subject matter knowledge.
Ability to direct the work of others, for jobs requiring supervision.
Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
* - 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:
Occasional evening and weekend hours.
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.
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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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu.Stanford University is an eq...ual opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.