The Stanford Laboratory for Cell and Gene Medicine (SLCGM) is seeking a Manufacturing Specialist (CPDMP1) to perform process development and clinical materials biomanufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.
- 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.
- Experience with iPSCs desired
- Aseptic technique experience preferred
- cGMP experience is preferred
- Knowledge and following SOPs and batch records 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
- 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.
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 requires working in a cGMP clean room environment.
- Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
- Position may work with human embryonic stem cells (hESCs).
- 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 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
- Schedule: Full-time
- Job Code: 4927
- Employee Status: Regular
- Grade: F
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 88167