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Clinical Process Development & Manufacturing Professional 1

Employer
Stanford University
Location
Stanford, CA
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Employment Type
Full Time
Institution Type
Four-Year Institution
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Job Details

DESIRED QUALIFICATIONS:

  • Knowledge and following SOPs and batch records preferred.
  • Aseptic technique and cell culture experience preferred
  • Experience with viral vector production, molecular biology, upstream and downstream processing preferred
  • cGMP experience is preferred 
  • Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules

 

EDUCATION & EDUCATION (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
  • 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 cGMP environment requirements.

     

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    CERTIFICATIONS & LICENSES:

     

    None

     

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

    •  

    The Stanford Laboratory for Cell & Gene Medicine (LCGM) is seeking a Clinical Process Development & Manufacturing Professional I (Manufacturing Assistant/Associate) focused on clinical Viral Vector products. LCGM is a GMP 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.

     

    LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. We invite you to join our team!

     

    Learn more about our team here: https://med.stanford.edu/lcgm.html

     

    Duties include: 

     

  • Plan, prepare for and perform viral vector materials biomanufacturing campaigns typically as an operator or a verifier. Prepare final formulated viral vector products for clinical trials within production timelines and manufacturing schedules.

  • Perform components of process development and technology transfer for viral vector production, and optimization activities in transitioning and translating pre-clinical, benchtop research into clinical phase. This includes testing and process optimization for upstream and downstream processing at the small scale manufacturing platforms and using novel bioreactors. 

  • Help with general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed
  • 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 (BRs). 
  • 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. 

  • Perform preparation activities of assigned cGMP manufacturing projects. 

     

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    *- Other duties may also be assigned

    Responsibilities

    Core Duties:

    • Plan, prepare for and perform human clinical materialsbiomanufacturing campaigns typically as a verifier. Prepare finalformulated cellular products for clinical trials within productiontimelines and manufacturing schedules.

    • Plan and perform components of process development and technologytransfer for manufacturing of clinical materials, scale-up/scale-out andoptimization activities in transitioning and translating pre-clinical,benchtop research into phase appropriate clinical trials.

    • Perform upstream and downstream components of assigned cGMPproject(s)

    • Identify, document and report operating excursions and facilitydeficiencies; make recommendations for process improvements anddocumentation 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 formanufacturing; outlining overall and per/patient costs for projectmaterials and supplies.

    • Devise and revise methods and/or processes for SOP andManufacturing Batch Records.

    • Independently track, verify and ensure cGMP grade raw materialsfor biomanufacturing. Identify and plan for supply chain and rawmaterials lead times for scheduled campaigns.

    • May prepare and submit abstracts or papers for publication inpeer-reviewed journals and/or presentation at scientific conferences.Present results during internal meetings.

    Minimum Education andExperience

    Bachelor's degree in related scientific field or an equivalentcombination of education and experience.

    Knowledge, Skills and Abilities:

    • Strong understanding of biological scientific principles

    • Working experience with aseptic cell culture

    • Strong computer skills and ability to learn quickly and mastercomputer programs, databases and scientific applications

    • Ability to work under deadlines with minimal supervision

    • Ability to maintain relationships and communicateeffectively

    • Excellent organizational skills and demonstrated ability tocomplete detailed work.

    • Maintain knowledge of cGMP environment requirements.

    Organization

    Change the world. And yourself.

    Stanford University has changed the world, over and over again.

    We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career. 

    At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment.

    Stanford Facts at a Glance

    Opened 1891

    Student Enrollment

    • Undergraduates: 6,980
    • Graduates: 8,897

    Campus

    • 8,180 contiguous acres in six governmental jurisdictions
    • Nearly 700 major buildings
    • 97% of undergraduates live on campus

    Research

    • 5,300 externally sponsored projects
    • $1.33 billion total budget

    Faculty

    • 2,043 faculty members
    • 21 Nobel laureates are currently members of the Stanford community
    • 5:1 student to faculty ratio

    Stanford University is an Equal Employment Opportunity and Affirmative Action Employer and is committed to recruiting and hiring qualified women, minorities, protected veterans and persons with disabilities.

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