Cellular Production Associate II-III | GenomeWeb

Cellular Production Associate II-III

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

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.

JOB SUMMARY
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.

SCOPE OF 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.
- Rotating evening and weekend shifts will be required of the position.
- Assist department management in the planning and scheduling of manufacturing operations.
- Provide guidance and training to junior staff

MINIMUM QUALIFICATIONS
- Bachelor's degree or higher in a biological science and a minimum of five years (Cell Production Associate II) to 8 years (Cell Production Associate III) of postgraduate experience related to process development and/or cGMP manufacturing.
- Experience writing or revising standard operating procedures and batch records.
- 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.

We are a VEVRAA Federal Contractor

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