Stanfords Laboratory for Cell and Gene Medicine (LCGM) in the Stem Cells and Cellular Therapeutics Operations (SCCTO) is offering an exciting new professional opportunity specifically created for its newly built current Good Manufacturing Practice (cGMP) facility. Stanford Health Care (SHC), Lucile Packard Childrens Hospital (LPCH), and the Stanford University School of Medicine (SOM) are jointly developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients. The LCGM offers a team-based approach to process development and manufacturing services to Stanford Medicine investigators to develop and implement leading-edge cell and gene-based therapies for Phase I and II clinical trials.
The Data Analytics Manager will work independently and in collaboration with a multi-disciplinary team of professionals including Quality Systems, Regulatory Affairs, Scientific, Operations and Business & Administration teams and will manage and analyze Big and diverse data from multiple GMP facility software, equipment and scientific instrumentation including Flow Cytometry, Chromatography, Device Controllers, Automation Controllers. The Data Analytics Manager will track and monitor environmental trending data and collaborate with Scientific and Quality Systems staff to identify problems and track impact and effect of proposed solutions. In addition, the Data Analytics Manager will identify and implement software solutions as necessitated by LCGM operations requirements and act as the primary/key liaison with University and School of Medicine IT support to manage multiple data, data storage, networking, server, software installation/deployment/qualification issues and tasks and will facilitate data transfer and exchange between SHC, LPCH and SOM systems. The role includes data analysis and reporting for LCGM in order to meet all compliance regulations and standards.
This role offers task diversity and is geared for professional development opportunities. The LCGM is a supportive, team-based environment that fosters work-life balance and a love-your-job philosophy. Join our team!
Prioritize and extract data from a variety of sources such as notes, survey results, medical reports, and laboratory data, and maintain its accuracy and completeness. Determine additional data collection and reporting requirements. Design and customize reports based upon data in the database. Oversee and monitor regulatory compliance for utilization of the data. Use system reports and analyses to identify potentially problematic data, make corrections, and eliminate root cause for data problems or justify solutions to be implemented by others. Create complex charts and databases, perform statistical analyses, and develop graphs and tables for publication and presentation. Serve as a resource for non-routine inquiries such as requests for statistics or surveys. Test prototype software and participate in approval and release process for new software. Provide documentation based on audit and reporting criteria to investigators and research staff.
* - Other duties may also be assigned.
DESIRED QUALIFICATIONS: Bachelors degree and 5 years of relevant experience. Experience with software implementation; relational database build is a plus. Prior experience in a manufacturing setting and working with Big Data is desirable. Experience with data collection and interpretation of scientific instrumentation (such as Flow Cytometry, Chromatography, Device Controllers, Automation Controllers) is desirable. Statistical analysis/environmental trend analysis in a GMP setting is desirable.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years of relevant experience or combination of education and relevant experience. Experience in a quantitative discipline such as economics, finance, statistics or engineering.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Substantial experience with MS Office and analytical programs statistical analysis software and/or other analytic software Excellent writing and analytical skills. Ability to prioritize workload. Independent worker and team-oriented Excellent communication (written/oral) skills
CERTIFICATIONS & LICENSES:
Sitting in place at computer for long periods of time with extensive keyboarding/dexterity. Occasionally use a telephone. Rarely writing by hand.
* - 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.
Some work may be performed in a laboratory or field setting.
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 d...edicated 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 equal 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.