Process Development and Manufacturing Scientist

Location
Stanford
Posted
Sep 22, 2017
Institution Type
Four-Year Institution


Stanford University

Process Development and Manufacturing Scientist

Job Number:
76414

The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University is seeking a Process Development and Manufacturing Scientist (Stanford series: Research and Development Scientist and Engineer 2). The LCGM is a ~10k ft2 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.

The Process Development and Manufacturing Scientist will apply advanced technical principles, theories, and concepts while assigned to a project or as project lead for a single or all phases of a major engineering or scientific research project/program. S/he will provide highly specialized biological product manufacturing and support and expert consultation, as well as identify and design solutions to a wide range of unique manufacturing problems and other pre-clinical/clinical research and development activities. In addition, s/he will focus on flow cytometry and cell sorting for process development and manufacturing in translational medicine. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.

Duties include:
  • Interact with investigators or clients and provide leadership and scientific expertise in the planning, implementation and manufacturing phase of major projects. Design and develop complex and specialized equipment and solutions.
  • Work in collaboration with senior Manufacturing, Regulatory and Quality Systems staff members. Provide technical direction to other research staff, engineering associates, technicians, and/or students; facilitate workshops and demonstrations on research methods; educate and train users on research methodology and effective tools and techniques. Collaborate with other positions in facility to ensure efficient operation of facility.
  • Develop and perform process development experiments on various blood, tissue and viral vector products. Involves independent work on isolation, culture (tissue culture vessels, bags, bioreactors), sorting, genetic modification and characterization of cells with a focus on flow cytometry and cell sorting. Will also develop standard operating procedures, batch records and product specifications. Includes assembling raw materials, following specific standard operating procedures, aseptic technique, completing batch records, reporting deviations. Design scale-up and scale-out process development experiments to meet clinical material requirements.
  • Perform and supervises manufacturing of clinical materials (cell and viral vector products) using magnetic beads and flow cytometry technologies, bioreactors, tangential flow, chromatographic and other contemporary methods. Develop novel cell substrates, antibodies, molecular and cellular reagents in support of clinical manufacturing efforts.
  • Present projects and data to existing and potential clients. Contribute to or co-author published articles, presentations, or scientific papers; identify research and development funding opportunities. Writes, submits and addresses reviewer comments related to novel methods in process development and manufacturing.

    * - Other duties may also be assigned



    DESIRED QUALIFICATIONS:
    Understanding of principles and compliance with cGMP and raw materials and documentation requirements. Expertise in flow cytometry and cell sorting.

    EDUCATION & EXPERIENCE (REQUIRED):
    Bachelor's degree and five years of relevant experience, or combination of education and relevant experience in biological field.

    KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
  • Expert knowledge of the principles of molecular biology, biological process engineering and related natural sciences.
  • Demonstrated project leadership experience.
  • Demonstrated experience leading and/or managing technical professionals.

    PHYSICAL REQUIREMENTS*:
  • Frequently grasp lightly/fine manipulation, perform desk-based computer tasks, lift/carry/push/pull objects that weigh up to 10 pounds.
  • Occasionally stand/walk, sit, twist/bend/stoop/squat, grasp forcefully.
  • Rarely kneel/crawl, climb (ladders, scaffolds, or other), reach/work above shoulders, use a telephone, writing by hand, sort/file paperwork or parts, operate foot and/or hand controls, lift/carry/push/pull objects that weigh >40 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 be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals /Asbestos, confined spaces, working at heights 10 feet, temperature extremes, heavy metals, unusual work hours or routine overtime and/or inclement weather.
  • May require travel.


    Job: Research

    Location: School of Medicine
    Schedule: Full-time
    Classification Level:

    To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu

    Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.






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