Job Number: 88168
The Stanford Laboratory for Cell and Gene Medicine (SLCGM) is seeking a PDM Associate(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.
*- Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field or an equivalent combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
CERTIFICATIONS & LICENSES:
*- 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.
- Schedule: Full-time
- Job Code: 4927
- Employee Status: Regular
- Grade: F
- Department URL: http://police.stanford.edu/
- Requisition ID: 88168
Location: School of Medicine, Stanford, 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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