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Cell Therapy Production Associate I-III

Cell Therapy Production Associate I-III

Job ID 
10353
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Manufacturing

More information about this job

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Cellular Processing Facility is responsible for assisting in the preparation of all modified cell products that are given to patients who participate in Fred Hutchinson Cancer Research Center protocols.  A Production Associate is needed for clinical work to be done in a cleanroom environment (requiring special gowning and work procedures) and pre-clinical development.

Responsibilities

Duties may include, but are not limited to, processing human blood and tissue; establishing and maintaining cell cultures; cryopreservation, performing assays; compiling and analyzing data; preparing data summaries, charts, and graphs; operating analytical instruments; and documentation of all procedures.  A working knowledge of the following is highly preferred but not required:

 

  • The processing and establishment of human T-cell clones for clinical immunotherapy trials.
  • Performance of retrovirus-mediated gene transfers into human cells for clinical gene therapy trials.
  • Establishment and maintenance of human B-cell and skin fibroblast lines.
  • Complete required processing documentation including deviation reports, change control, product change over, etc.  
  • Perform review of GMP documentation.
  • Familiarity with the GMP/GTP federal regulations
  • Familiarity with ISO and USP guidelines

 

JOB DUTIES

 

  • Document all procedures extensively.  Maintain careful records, compile and compute data from assays, and prepare reports for presentation to group.
  • Monitor and maintain laboratory equipment.
  • Manage research databases.
  • Collaborate and coordinate work with team members and members of the Quality Control, Quality Assurance, and Cellular therapy laboratories.
  • Participate in support of the validation process.
  • Participate in proficiency and competency assessment on a routine basis.
  • Monitor and maintain equipment.
  • Assist in preclinical research and development.
  • Clean and maintain the facility.
  • Perform other responsibilities, as required.
  • Shift Schedule: 4 days/week, 10 hours/day. Sunday – Wednesday day shift available, 7AM – 5:30PM and Monday - Thursday, evening shift available 11AM - 9:30PM.
  • Assist department management in the planning and scheduling of manufacturing operations.
  • Provide guidance and training to junior staff

Qualifications

MINIMUM QUALIFICATIONS

  • Bachelor’s degree or higher in a biological science and a minimum of one year (Cell Production Associate I) to five years (Cell Production Associate II) to eight years (Cell Production Associate III) of postgraduate experience related to process development and/or cGMP manufacturing.
  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
  • Must have the ability to stand for long periods.
  • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
  • Experience establishing and maintaining long-term T-cell lines/clones preferred.
  • Computer skills highly desirable (Mac and PC).
  • Must be able to work well within a team environment and function with little supervision.

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.