Manufacturing Specialist

The Stanford Center for Cancer Cell Therapy (CCT) is seeking a Clinical Manufacturing Specialist (PDM2) to independently conduct clinical biomanufacturing for cell and gene therapies, consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Manufacturing Duties include:

• Lead CCT (Center for Cancer Cell Therapy) human clinical materials biomanufacturing campaigns primarily as an operator. Prepare final formulated cellular products for cancer therapy clinical trials within production timelines and manufacturing schedules. Mainly focused on CART and TCR based therapies.
• Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business & administration.
• Train on biomanufacturing procedures, Batch Records, or provide direction during tech transfer activities.
• Plan and perform upstream and downstream components of assigned cGMP projects.
• Identify strategies for innovation in production systems and manufacturing processes.
• Identify areas for culture or process optimization and common manufacturing deficiencies or gaps, to recommend for process improvements
• Identify operating excursions and facility deficiencies during manufacturing. Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records.
• Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per/patient costs for project materials and supplies and hours dedicated to complete all manufacturing steps.
• Determine need for, devise, and revise Standard Operating Procedures and Batch Records.
• Oversee cGMP grade raw materials acquisition for biomanufacturing.
• Participate in discussions with CCT Process Development and Manufacturing teams, providing analyzed data and feedback when appropriate.
• Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.

The Center for Cancer Cell Therapy is a part of the Stanford Cancer Institute (SCI), which is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.

• - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• Bachelor's degree in chemistry, microbiology, biological sciences etc.
• Experience with CAR T, TCR, T cells, gene editing, and cell and gene therapy process development/manufacturing desired.
• Aseptic technique and cell culture experience is preferred
• cGMP experience is preferred
• Knowledge of and experience generating SOPs, batch records, and other documentation for clinical manufacturing of cell and gene therapy products is preferred
• Experience with tech transfer, engineering/qualification runs a plus
• Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules
• Experience with following assays a plus: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR
• Experience with the following software a plus: Prism/GraphPad, FlowJo/Cytobank, Microsoft Word/Excel/Powerpoint, a plus: SnapGene, DOE Software/JMP.

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.

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 requires working in a cGMP clean room environment.
• Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
• Position may work with cancer cell lines or 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. 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, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu.