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Biologics QC Associate II

Biologics QC Associate II

Job ID 
10310
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 (FHCRC), 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. FHCRC’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, FHCRC 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 Biologics Quality Control laboratory performs in-process, release, and stability testing assays for viral vector, recombinant proteins, and antibody-drug conjugate products manufactured in our GMP Biologics Processing Facility.  The group also develops, transfers, and qualifies new analytical methods to support product characterization, process development, and product comparability studies.  In addition, the group qualifies instrumentation and equipment to support these activities, and actively supports clinical trial regulatory submissions.

 

We are searching for a dynamic, organized, and detail-oriented laboratory professional to join our team.

Responsibilities

The Biologics Quality Control Associate II performs analytical methods to support the characterization, release, and stability testing of protein-based therapeutics in a GMP laboratory environment. This position represents Biologics QC throughout the project lifecycle (i.e. initiation, implementation, sun setting) and continuously interacts with laboratory management, project sponsors and/or their representatives. The position performs analytical methods such as SDS-PAGE, IEF, HPLC, ELISAs, and endotoxin, and conducts aseptic procedures ranging from routine environmental monitoring to fill/finish of final products. This position must complete all activities precisely/accurately, and document results appropriately. Additional laboratory responsibilities may include development and transfer of analytical methods to/from internal and external partners. Administrative duties include creation/revision of laboratory quality systems and standard operating procedures, environmental/stability/contract laboratory testing data management and trending, and routine maintenance of the lab to ensure a continued state of regulatory compliance.

Qualifications

Required Skills:

  • BS/MS in a biological science with 4+ years w/ BS (2+ years w/ MS) with a background in biologics, recombinant protein therapeutics, or similar field.
  • Working knowledge of GMPs, 21 CFR Part 11/210/211/600, ICH and USP guidelines.
  • Hands-on experience in the performance of one or more of the following protein-based analytical methods for characterization/release/stability (ELISA, HPLC, SDS-PAGE, IEF, cell-based bioassays).
  • Demonstrated ability to operate in an aseptic environment (i.e. cell culture, sterile fill/finish, environmental monitoring, etc.).
  • Experience in the generation of standard operating procedures, test methods, stability reports, or other documents intended for use in a GxP environment and regulatory filings.
  • Excellent verbal and written communication skills with demonstrated ability to work both as an individual contributor and in a dynamic team environment.

Preferred Skills:

  • Experience in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
  • Familiarity with the administration and conduct of environmental monitoring programs (identification, sample frequency/location, periodic trending reports).
  • Knowledge of biologics manufacturing and fill/finish processes.
  • Familiarity with data analysis/statistical software packages (e.g. Empower, JMP, Prism, LIMS).