The Stanford Laboratory for Cell and Gene Medicine (SLCGM) is seeking a Manufacturing Specialist 2 (CPDMP2) 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.
• Lead human clinical materials biomanufacturing campaigns primarily as an operator. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
• 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 process development activities.
• Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.
• 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.
• 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.
• Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.
• Bachelor's degree in chemistry, microbiology, etc.
• Aseptic technique experience is preferred
• cGMP experience is preferred
• Knowledge and following SOPs and batch records preferred
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:
• 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.
• 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 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.
• Add or subtract physical requirements based on the requirements of your specific job. (remove this statement for posting)
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