Process Development and Manufacturing Associate (Stanford)

The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University School of Medicine is seeking a Manufacturing Associate for the Viral Vector team. The LCGM is a ~20k ft2 multi-product Cell and Gene Therapy manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Childrens Hospital (LPCH) and Stanford Health Care (SHC). It supports by developing first in human 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.

The Associate hired for this role will have a role focused on clinical Viral Vector products. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.

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

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

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 $40.52 to $44.33 hourly.

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 & 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

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.