Analytic Dev/QC Associate III

Job ID
21771
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Quality

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 

The Quality Control laboratory performs in-process and release testing in support of Human Gene Therapy Phase I/II clinical research studies. We are looking for a dynamic, skilled, and detail-oriented Analytic Developer/Quality Control Associate III to join our team. The position will perform routine cell-based potency assays, as well as microbial safety assays utilizing ELISA, microscopy, and qPCR techniques. In addition, the position will be required to follow and maintain laboratory quality systems in our GMP environment. Eventually, the position may also be required to train on flow cytometry-based methods.

Responsibilities

  • Perform in-process, lot release, and stability cGMP testing of raw materials and human gene therapy products
  • Review assays performed by peers
  • Write SOPs and test methods
  • Perform deviation and out of specification (OOS) investigations
  • Maintain laboratory cell lines
  • Participate in environmental monitoring activities
  • Maintain equipment
  • Perform general activities in accordance with SOPs and laboratory quality systems

Qualifications

MINIMUM QUALIFICATIONS:

  • Bachelor’s degree in a life sciences field (Biology, Chemistry, or related scientific major) with 5+ years (3+ years MS), preferably with a background in biologics and/or cellular therapeutics
  • 5 years of experience in a laboratory setting or equivalent
  • Hands-on experience with microtiter cell-based assays
  • Experience with aseptic and cell culture techniques
  • Experience with typical GMP Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.)
  • Good written and oral communication skills
  • Strong communication and writing skills with demonstrated ability to work in a dynamic team environment
  • Physical requirements: must have the abiliy to life a minimum of 25 pounds, the ability to stand of extended periods.
     

PREFERRED QUALIFICATIONS:

  • Experience with cytotoxicity, bacterial endotoxin, and qPCR testing
  • Experience with Environmental Monitoring (EM) programs  

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 hrops@fredhutch.org or by calling 206-667-4700.

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