Process Development and Manufacturing Assistant Prof 1(GMP Certificate Program)
Location: Stanford, California
Internal Number: 98984
Stanford Cell & Gene Good Manufacturing Practices (GMP) Certificate Program
Be an Employee-in-Training and Earn while you Learn as you START your bright biomedical career. We aim to increase opportunity, access, equity, and inclusion as we develop a skilled entry-level cell and gene therapy manufacturing and quality workforce.
The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University School of Medicine is seeking a Manufacturing Assistant for the process development and manufacturing team. The LCGM is a multi-product Cell and Gene Therapy 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). It supports by developing first in human 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.
The person hired for this role will join a Process Development and Manufacturing team comprised of scientists, manufacturing specialists, and manufacturing associates. The specialist hired for this role will have a role focused on manufacturing cell products for the phase I/II clinical trials supported by Stanford Center for Definitive and Curative Medicine (CDCM: https://med.stanford.edu/cdcm). Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
Innovations in Cell & Gene Therapy represent some of the most promising advancements in the field of biotechnology today. Behind these extraordinary innovations is a workforce that is expected to grow between 50 and 100 percent in the years to come. LCGM is looking to address this gap by creating a NEW Cell & Gene GMP Certificate Program.
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 is a fixed term position of up to 18 months.
*Plan, prepare for and perform human clinical materials biomanufacturing campaigns typically as an operator or a verifier. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
*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.
*Perform upstream and downstream components of assigned cGMP project(s)
*Identify, document and report operating excursions and facility deficiencies; make recommendations for process improvements and documentation improvements including Standard Operating Procedures (SOP) and manufacturing Batch Records (BR).
*Devise and revise methods and/or processes for SOP and Manufacturing Batch Records.
*Independently track, verify and ensure cGMP grade raw materials for biomanufacturing. Identify and plan for supthere ply chain and raw materials lead times for scheduled campaigns.
*May be asked to help plan and perform components of process development and technology transfer for manufacturing of clinical materials, scale-up/scale-out and optimization activities in transitioning and translating pre-clinical, benchtop research into phase appropriate clinical trials
*- Other duties may also be assigned
Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $66,000.00 to $75,000.00
*Knowledge and following SOPs and batch records preferred
*Aseptic technique experience preferred
*Understanding of cGMP is preferred
*Mammalian cell culture experience preferred
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field or an equivalent combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
*Strong understanding of biological scientific principles
*Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications
*Ability to work under deadlines with minimal supervision
*Ability to maintain relationships and communicate effectively
*Excellent organizational skills and demonstrated ability to complete detailed work.
*Maintain knowledge of cGMP environment requirements.
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 his or her job.
*May require working in close proximity to blood borne pathogens.
*Ability to work with unpredictable manufacturing schedules.
*Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
*Position primarily requires working in a cGMP clean room environment.
*Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
*Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves.
*May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/ Chemicals, and confined spaces.
May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.
Why work at Stanford?Stanford University has changed the world, over and over again.We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment. How will it change you?