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.

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
Experience with chromatography and Stirtrd tank (STR) or Wave bioreactors.
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 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 20 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 requires working in a cGMP clean room environment.
Position may work with viruses: lentiviruses, and/or retroviruses, adeno-associated viruses,.
Position may work with human embryonic stem cells (hESCs).
Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
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 including weekends. 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: 108820
Work Arrangement : On Site

Process Development & Manufacturing Specialist-Vector

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Stanford, California