Stanford University is seeking a Clinical Process Development & Manufacturing Professional 2 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.

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

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 $47.72 to $53.23 hourly.