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Analytic Developer/Quality Control Associate I/II at UNAVAILABLE

Analytic Developer/Quality Control Associate I/II

UNAVAILABLE Seattle, WA Full-Time


Overview

The 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 Hutchs global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the worlds 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 worlds 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 candidate 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

Analytic Developer/Quality Control Associate I:

  • Perform routine microbiological, flow cytometry and cell culture based potency assays in support of manufacturing and process development activities.
  • Perform method development including assay qualification and generation of approved test methods.
  • Further responsibilities include sample receipt/distribution, communication with internal/external laboratories, environmental monitoring activities and maintenance of the lab equipment in state of regulatory compliance.

Analytic Developer/Quality Control Associate II:

  • 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 to SOPs and laboratory quality system


Qualifications

Analytic Developer/Quality Control Associate I

MINIMUM QUALIFICATIONS:

  • At least a minimum of one year of experience in analytical methods used in QC release testing and characterization of immune cells and/or stem cells
  • Hands on experience with analytical methods that such as:  FACS, cell culture based functional assays (e.g.  target cell killing, cytokine release), quantitative PCR, genetic and proteomic profiling, ELISA
  • Experience in following and completing GMP test methods and documentation intended for product release testing and characterization as required under FDA and ICH guidelines
  • Experience in executing protocols for the qualification/validation of methods and equipment
  • Good communication skills and writing ability
  • Familiarity with data analysis software packages and general statistical concepts and methods
  • Bachelor's degree (or higher)

Analytic Developer/Quality Control Associate II

MINIMUM QUALIFICATIONS:

  • Bachelors degree in a life sciences field with 2+ years, preferably with a background in biologics and/or cellular therapeutics
  • 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

PREFERRED QUALIFICATIONS:

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

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 [ Email address blocked ] - Click here to apply to Analytic Developer/Quality Control Associate I/II or by calling
206-667-4700
.

Recommended Skills

  • Analytical
  • Attention To Detail
  • Bacteria Cultures
  • Biopharmaceuticals
  • Cell Biology
  • Cell Cultures
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