From Stanford University's posting. “We” and “our” refer to the employer.
Responsible for scientific and analytical process development and clinical biomanufacturing of human clinical materials and therapies, such as, at the Laboratory for Cell and Gene Medicine for treatment of patients with incurable diseases according to the principles of current Good Manufacturing Practice (cGMP) as described in the Code of Federal Regulations (CFR) Title 21 (parts 21, 211).
DESIRED QUALIFICATIONS:
Knowledge and following SOPs and batch records preferred.
Aseptic technique and cell culture experience preferred
Experience with viral vector production, molecular biology, upstream and downstream processing preferred cGMP experience is preferred
Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules
EDUCATION & E
DUCATION (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:
None
PHYSICAL REQUIREMENTS*:
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.
WORKING CONDITIONS:
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
The Stanford Laboratory for Cell & Gene Medicine (LCGM) is seeking a Clinical Process Development & Manufacturing Professional I
(
Manufacturing Assistant/Associate) focused on clinical Viral Vector products. 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 Phase I/II 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!
Learn more about our team here: https://med.stanford.edu/lcgm.html
Duties include:
Plan, prepare for and perform viral vector materials biomanufacturing campaigns typically as an operator or a verifier. Prepare final formulated viral vector products for clinical trials within production timelines and manufacturing schedules.
Perform components of process development and technology transfer for viral vector production, and optimization activities in transitioning and translating pre-clinical, benchtop research into clinical phase. This includes testing and process optimization for upstream and downstream processing at the small scale manufacturing platforms and using novel bioreactors.
Help with general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed
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 (BRs).
Independently track, verify and ensure cGMP grade raw materials for biomanufacturing. Identify and plan for supply chain and raw materials lead times for scheduled campaigns.
Perform preparation activities of assigned cGMP manufacturing projects.
*- Other duties may also be assigned
Responsibilities
Core Duties: Plan, prepare for and perform human clinical materials biomanufacturing campaigns typically as a verifier. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
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.
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).
Contribute to detailed manufacturing budget; including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outlining overall and per/patient costs for project materials and supplies.
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 supply chain and raw materials lead times for scheduled campaigns.
May prepare and submit abstracts or papers for publication in peer-reviewed journals and/or presentation at scientific conferences.
Present results during internal meetings.
Minimum Education and
Experience
Bachelor's degree in related scientific field or an equivalent combination of education and experience.
Knowledge, Skills and Abilities: Strong understanding of biological scientific principles
Working experience with aseptic cell culture
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.
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