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QC Associate II, Analytical Development

QC Associate II, Analytical Development

Job ID 
8950
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Quality

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 FHCRC Quality Control/Analytical Development laboratory performs in-process and release testing assays for T-cell and stem cell therapeutic products manufactured in our GMP Cell Processing Facility.  The group also develops and transfers new analytical methods used to characterize the products, and support process development and product comparability.  In addition, the group qualifies test methods and equipment to support these activities and actively supports regulatory submissions.

Responsibilities

The Quality Control/Analytical associate will primarily focus on the development and performance of flow cytometry and plate-based analytical methods in a GMP laboratory environment. The position is also required to perform microbiological assays such as endotoxin, gram stain and mycoplasma testing. Additional responsibilities include development and/or transfer of analytical methods from internal/external partners, generation of laboratory quality systems and standard operating procedures, sample management, and routine maintenance of the lab to ensure a continued state of regulatory compliance.

Qualifications

Required Skills:

  • BS/MS in a biological science with 3+ years (1+ years MS) with a background in biologics and/or cellular therapeutics.
  • Hands-on experience in the performance of flow cytometry methods to characterize cells (e.g. using a Canto, LSR, Guava etc.).
  • Familiarity with data analysis/statistical software packages (e.g. FlowJo, JMP, etc.).
  • Strong communication and writing skills with demonstrated ability to work both as an individual contributor and in a dynamic team environment.

Preferred Skills:

  • Performance of cell culture based functional assays (e.g. target cell killing, cytokine release, etc.), q/RT-PCR, ELISA, and/or microbial methods.
  • Experience in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
  • Experience generating documents intended for use in a GxP environment or regulatory filings.
  • Prior hands-on work in a GxP laboratory environment.