Manufacturing Specialist

School of Medicine, Stanford, California, United States

Research

Post Date Aug 20, 2024

Requisition # 104298

The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University School of Medicine is seeking a Manufacturing Specialist for the process development and manufacturing team. The LCGM is a20k ft2multi-product Cell and Gene Therapy 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). 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 person hired for this role will join a Process Development and Manufacturing team comprised of scientists, manufacturing specialists, and manufacturing associates. The specialist hired for this role will have a role focused on manufacturing cell products for the phase I/II clinical trials supported by Stanford investigators or outside collaborators. 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:

· Lead human clinical materials biomanufacturing campaigns primarily as an operator or verifier. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.

· Coordinate campaign activities with all functional teams: operations, quality control, and quality assurance.

· Train on manufacturing procedures, Batch Records, and associated Standard Operating Procedures (SOPs).

· 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.

· Determine need for, devise, and revise (SOPs) and Batch Records.

· Assist with maintaining inventory of cGMP grade raw materials for biomanufacturing campaigns.

· Assist in training new staff on manufacturing procedures and SOPs.

· May be asked to assist during process development activities.

*- 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 $40.38 to $46.63 hourly.

DESIRED QUALIFICATIONS:

Experience with one or more of the following:

· cGMP experience in cell and gene therapy

· Experience with flow cytometry analysis and cell sorting

· Gene editing using CRISPR Cas9

· Experience with clinical scale equipment: magnetic cell enrichments in a closed system

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related scientific field and two years of related experience, or Master’s degree, or an equivalent combination of education and relevant work experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

· Strong biological scientific background

· Working experience with aseptic cell culture

· cGMP clean room experience

· 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.

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 under deadlines and meet/ exceed 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, face masks, 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, working at heights.

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.

Additional Information

• Schedule: Full-time

• Job Code: 1016

• Employee Status: Regular

• Grade: G

• Department URL: http://pediatrics.stanford.edu/

• Requisition ID: 104298

• Work Arrangement : On Site