Manufacturing Associate Job at Stanford University in Palo Alto

Cancer Cell Therapy – Manufacturing Associate (Onsite, 100% FTE)

The Stanford Center for Cancer Cell Therapy (CCT) is seeking a Manufacturing Associate (PDM1) to perform clinical cell therapy manufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Duties include:

• Plan, prepare for and perform human clinical materials biomanufacturing campaigns typically as a verifier. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules. Mainly focused on CAR T cell therapies.
• Train on biomanufacturing and cGMP procedures.
• Plan and perform components of process development and technology transfer for manufacturing of clinical materials, scale-up/scale-out and optimization activities in transitioning and translating pre-clinical, benchtop research into phase appropriate clinical trials.
• Perform upstream and downstream components of assigned cGMP projects.
• 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 (BR). Document deviations and provide recommendations for Corrective and Preventative Actions (CAPA).
• Contribute to detailed manufacturing budget; including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outlining overall and per/patient costs for project materials and supplies.
• Devise and revise methods and/or processes for SOP and Manufacturing Batch Records.
• 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.
• May prepare and submit abstracts or papers for publication in peer-reviewed journals and/or presentation at scientific conferences. Present results during internal meetings.

DESIRED QUALIFICATIONS:

• Bachelor’s degree in biology, bioengineering, chemistry or related scientific field.
• Aseptic technique and cell culture experience is preferred.
• cGMP experience is preferred.
• Experience with CAR T, T cells, gene editing, and cell and gene therapy manufacturing is desired.
• 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):

• General understanding of biological scientific principles.
• Aseptic technique and mammalian cell culture experience.
• General understanding on how to use laboratory equipment: biosafety cabinet, centrifuge, incubator, cell counter, micropipettes, etc.
• General understanding of current Good Manufacturing Practice (cGMP) guidelines.
• Computer skills and ability to learn quickly and master computer programs, databases and scientific applications.
• Strong attention to detail.
• Ability to work following Standard Operating Procedures (SOPs).
• Ability to work in a cleanroom space donning special sterile gowning.
• Ability to work under deadlines with minimal supervision.
• Ability to maintain relationships and communicate effectively between multiple functional groups.
• Excellent organizational skills and demonstrated ability to complete detailed work.

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.

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 requires working in a cGMP clean room environment.
• Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
• 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.
• 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.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures.