This recruitment is for two (2) identical positions.
Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate II. This position will be prioritized to support quality control release testing and related activities for CAR T manufacturing for the Center for Cancer Cell Therapy (CCT), in the Stanford Cancer Institute consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the phase of the clinical investigation for treating patients with incurable diseases.
LCGM is a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children's Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in early stage clinical trials.
LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine's mission. We invite you to join our team!
Perform complex chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC), which constitute the quality, safety and efficacy of all analytical methods for clinical materials manufactured at Laboratory for Cell and Gene Medicine (LCGM).
Perform in-process and final product flow cytometry release testing for CAR T products for clinical infusion.
Develop and perform tests related to CAR T assays/analytical methods; collect, interpret, analyze and report data related to test results including investigation of out-of-specification and/or non-conforming test results.
Perform analytical method, analyze collected data, and determine specifications for each test method. Evaluate proposed specification changes and escalate to Functional Manager. Present data to stakeholders (PIs, CCT team, LCGM team).
Perform and document assay qualification as applicable per regulation requirements. Document execution of test methods according to test procedure, GMP, and good documentation requirements. Manage materials/supplies related to clinical materials manufacturing. Create selection criteria, justification and qualification of raw materials. Responsible for examining and documenting materials used in clinical materials manufacturing, consistent with defined, relevant quality standards and cGMP.
Participate in the evaluation of suppliers/contract testing lab including, but not limited to, auditing the manufacturer/vendor site, analyzing test methods, and establishing contract with supplier/vendor as applicable. Resolve issues associated with vendor/supplier and changes/deviations to the generation of materials/reagent.
Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date. Coordinate equipment implementation for use and decommissioning activities.
Investigate out-of-specification and/or non-conforming test results. Initiate, investigate as appropriate, and prepare deviation reports for SOPs and test methods with input from supervisor in order to implement prevention or corrective actions.
Perform QC Support tasks - e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc.
Coordinate the timely shipment of samples to contract laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).
* - Other duties may also be assigned
Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
Flow cytometry experience a plus.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, Biochemical Engineering, or Engineering) and three years' experience or an equivalent combination of education and relevant work experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
Strong analytical technical skills and experience with testing QC methods and concepts.
Good understanding of cGMP or International Organization for Standardization (ISO) requirements, quality systems.
Strong team-oriented, interpersonal skills and collaborative work style.
Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
Excellent organizational skills and attention to detail.
Excellent verbal and written communication skills.
CERTIFICATIONS & LICENSES:
Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 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 the job.
May require working in close proximity to blood borne pathogens.
Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights
May require extended or unusual work hours (including weekends) based on research requirements and business needs.
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
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, 12000 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 is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.