Manufacturing Specialist (CAR-T)
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 clinical trials.
This Manufacturing Specialist will perform CAR-T manufacturing for patients with recurring or refractory B-Cell Malignancies. 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!
This recruitment is for up to four (4) full-time (100% FTE) positions.
Duties include: Plan approach to experiments in support of research projects in lab and/or field based on knowledge of scientific theory.
Independently conduct experiments; maintain detailed records of experiments and outcomes.
Apply the theories and methods of a life science discipline to interpret and perform analyses of experiment results; offer suggestions regarding modifications to procedures and protocols in collaboration with senior researcher.
Review literature on an ongoing basis to remain current with new procedures and apply learnings to related research.
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.
Assist with orientation and training of new staff or students on lab procedures or techniques.
*- 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. Demonstrated performance to use knowledge and skills when needed.
Demonstrated ability to apply theoretical knowledge of science principals to problem solve work.
Ability to maintain detailed records of experiments and outcomes.
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
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.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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