The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University is seeking a Manufacturing Associate (Stanford series: Life Science Research Professional 2). The LCGM is a ~10k ft2 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 Phase I/II clinical trials. This Scientist will conduct CAR-T therapy manufacturing in support of LCGM's mission and in support of Cancer Immunology and Immunotherapy Program. This role works both independently and collaboratively across the 5 functional teams: Process Development & Manufacturing, Regulatory Affairs, Quality Systems, Operations and Finance & Administration.
This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
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 (lab and/or field) experiments for a major portion of the research project. Maintain detailed records of experiments and outcomes.
Interpret and analyze results, often where few guidelines exist. Based on prior results, contribute to development of new research protocols and procedures or adaptation of existing protocols.
Make recommendations on plan design and/or research direction to principal investigator.
Work with health and safety department to ensure lab complies with regulations and all required trainings.
Participate in multidisciplinary teams across different faculties or schools.
Oversee supply and equipment budget under supervision of principal investigator or business manager.
Perform ongoing literature review to remain current with new procedures and related research; present findings for lab work group.
Contribute substantively to the preparation of papers for publication, especially in the results section. May contribute to publication of findings and present ongoing work and findings to colleagues at academic conferences.
Supervise (either formally or informally) staff or students as needed, including oversight and instruction on techniques, as well as consultation on project work. Serve as technical resource for other research staff.
Perform general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed. May assist with purchasing laboratory equipment.
* - Other duties may also be assigned
Bachelor's degree in chemistry, microbiology, etc.
Aseptic technique experience is preferred
cGMP experience is preferred
Knowledge and following SOPs and batch records preferred
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field and three years of related experience, or Master's degree.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Comprehensive understanding of scientific principles.
General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications.
Strong analytical skills and excellent judgment.
Ability to work under deadlines with general guidance is essential.
Excellent organizational skills and demonstrated ability to accurately complete detailed work.
Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds.
Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts.
Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls.
Must have correctible vision to perform duties of the job.
Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours.
Ability to lift heavy objects weighing up to 50 pounds.
Ability to work in a dusty, dirty, and odorous environment.
Position may require repetitive motion.
* - 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. Additional PHYSICAL REQUIREMENTS:
Work in ISO-7 (209E Class 10,000) clean room for multiple hours at a stretch depending on needs and demands of project and product being manufactured WORKING CONDITIONS:
May require working in close proximity to blood borne pathogens.
May require work in an environment where animals are used for teaching and research.
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 require extended or unusual work hours based on research requirements and business needs.
Additional WORKING CONDITIONS:
Will work with viruses: lentiviruses, adeno-associated viruses, retrovirus
May work with human embryonic stem cells (hESCs)
Complete Training for working in manufacturing clean rooms
May work long hours during manufacturing and product release (which may include weekend work for manufacturing and product release); required to stay until product is released
Complete all required training for the facility and for each project related to safety, quality, regulatory and operations
Location: School of Medicine, 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, 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.