Grade: G

FTE: 100%

The Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Clinical Process Development & Manufacturing Professional 2 (Manufacturing Specialist II) to independently conduct major portions of complex 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.

The Stanford Laboratory for Cell and Gene Medicine is a state-of-the-art cGMP facility providing support and services for clinical investigators during the entire arc of translational research activities including consulting, technology transfer, process and analytical development, clinical manufacturing and regulatory affairs.

Duties include:

• Lead human clinical materials biomanufacturing campaigns primarily as an operator. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
• Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business & administration.
• Train on biomanufacturing procedures, Batch Records or provide direction during process development activities.
• Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.
• Plan and perform upstream and downstream components of assigned cGMP projects.
• Identify strategies for innovation in production systems and manufacturing processes.
• Identify operating excursions and facility deficiencies during manufacturing. Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records.
• Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per/patient costs for project materials and supplies and hours dedicated to complete all manufacturing steps.
• Determine need for, devise and revise Standard Operating Procedures and Batch Records.
• Oversee cGMP grade raw materials acquisition for biomanufacturing.
• Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.

*- Other duties may also be assigned