Analytic Dev/QC Assc III

Job ID
21857
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Manufacturing

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 Analytic Developer/QC Associate III is responsible for Quality Control (QC) cGMP testing activities in support of Human Gene Therapy Phase I/II clinical trials.  


This position will primarily focus on performing transfer, qualification, and validation of analytical test methods using FDA and ICH guidelines. In addition, the position will perform testing as needed in support of the Cell Processing and Biologics Production facilities (CPF and BPF). Cross-training on multiple assays will be required for this position as well as in laboratory quality systems.

Responsibilities

  • Lead and participate in analytical method transfer/qualification/validation activities
  • Participate in commissioning of laboratory instrumentation
  • Perform cGMP in-process, lot release, and stability testing of raw materials, intermediates, drug substance, drug product, and human gene therapy products
  • Review assays performed by peers
  • Perform deviation and out of specification (OOS) investigations
  • Write SOPs and test methods
  • Perform general laboratory activities in accordance to SOPs and laboratory quality systems

Qualifications

MINIMUM QUALIFICATIONS:

  • Bachelor’s or master’s degree in a life sciences field with 5+ years (3+ years MS), preferably with a background in biologics and/or cellular therapeutics
  • Knowledge of regulatory guidance documents/information for Analytical Procedures and Method Validation
  • Experience with ELISA, qPCR, gel electrophoresis, and HPLC methods
  • Good written and oral communication. Good presentation skills
  • Detail oriented, organized, proactive and self-motivated
  • Possess strong communication and teamwork skills
  • Ability to analyze data, assess/evaluate trends and make recommendations for improvement
  • Experience with typical Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.)

 

PREFERRED QUALIFICATIONS:

  • Knowledge of cGMP requirements for Phase I/II clinical trials
  • Familiarity with Chemistry. Manufacturing, and Controls (CMC) information for Investigational New Drug Applications
  • Experience with flow cytometry
  • Experience with microbial-based assays
  • Knowledge of aseptic and cell culture techniques   

 

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.  #ZR

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed