Production Specialist 1 - Stanford Blood Center : Job Details

Stanford University is seeking a Clinical Process Development & Manufacturing Professional 1 to perform 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.The people and programs comprising Stanford Radiology are world-renowned. Stanford Radiology continues to push the boundaries of innovation in physics and engineering to develop cutting-edge methods for enhanced anatomic and functional imaging. Our diverse multidisciplinary teams of scientists, together with industry collaborators, are creating new methods for the early detection of cancer using molecular imaging, nanotechnology, and systems biology. They also continue to develop improved and more targeted methods for least-invasive, and compassionate cancer patient care.Stanford Radiology delivers outstanding patient care using technology, innovation, and humanity. We educate the next generation of leaders in patient care and research. We develop the next generation of imaging technology, molecular imaging, in-vitro diagnostics, image-guided therapeutics, and informatics for precision health. We promote a culture of diversity, inclusion, transparency, and integrity.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.
• 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 project(s).
• 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).
• 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:
  • Must have aseptic knowledge and experience in working in the clean room environment.
  • Must know how to use the TruMotion telemanipulator arms and the Amercare Automatic Dose Dispenser.
  • Must have basic knowledge of chemistry.
  • Must have basic knowledge of chromatography: gas chromatography (GC), high-performance liquid chromatography (HPLC) and Thin Layer Chromatography (TLC).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.
    • Working experience with aseptic cell culture.
    • 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 current Good Manufacturing Practice (cGMP) environment requirements.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 radiation.
        • Ability to work with unpredictable manufacturing schedules.
        • Position may at times require the employee to work with or be in areas where hazardous materials are present.
        • Position requires working in a cGMP clean room environment.
        • 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.
        • 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.
        • May require delivering heavy boxes of medicine that can weigh up to 90 lbs.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 based on training and lessons learned. #J-18808-Ljbffr