Job Code: 4951 Job Grade: E The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University is seeking a Manufacturing Specialist (Life Science Research Professional 1). 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 Manufacturing Specialist will perform dermal graft manufacturing for patients with epidermolysis bulosa . 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!
Plan and perform experiments in support of research projects in lab and/or field based on knowledge of scientific theory. Interpret and perform basic analyses of results.
Review literature on an ongoing basis to remain current with new procedures and related research.
Offer suggestions regarding modifications to procedures and protocols in collaboration with graduate post-doctoral individuals.
Maintain detailed records of experiments and outcomes.
Contribute to publication of findings as needed. Participate in the preparation of written documents, including procedures, presentations, and proposals.
Help with general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed.
Help orient and train new staff or students.
*- Other duties may also be assigned
Bachelor's degree in chemistry, microbiology, etc.
Aseptic technique experience is preferred.
cGMP experience is preferred.
Knowledge of following SOPs and batch records preferred.
Strong analytical skills and excellent judgment.
EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in related scientific field.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
General understanding of scientific principles.
General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications.
Ability to work under deadlines with general guidance.
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.
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.
*- 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.
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.
Will work with viruses: lentiviruses, adeno-associated viruses, retroviruses
May work with human embryonic stem cells (hESCs)
Must 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
Must 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, 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.