• Senior Manager, TPP Quality Control

    Job ID
    11318
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Manufacturing
  • 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 (QC) department performs in-process and release testing assays for a wide range of Phase I/II clinical products manufactured in both the Cellular Processing Facility (CPF) and the Biologics Production Facility (BPF). Products range from autologous T-Cell therapies (CAR-T, T-Cell Receptors, and Tumor-Infiltrating Lymphocytes) to complex biological products including Lentiviral Vectors, Fusion Proteins and Monoclonal Antibodies. The QC group also develops and transfers new analytical methods used to characterize 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 Manager/Sr. Manager, reporting to the Head of Quality for the Therapeutics Product Program (TPP), will support the Cell Processing Facility (CPF) and Biologics Production Facility (BPF) operations. The QC Manager/Sr. Manager will interact with manufacturing personnel in the BPF and CPF, research scientists, physician investigators, Process Development, Quality Assurance and other scientific staff and external collaborators. 

     

    • Lead and champion quality control system integration between the Phase I/II Cellular Processing and the Biologics Production facilities
    • Integrate the Quality Control role into the BPF organization
    • Champion proactive identification and resolution of compliance gaps
    • Create additional quality control programs as required
    • Provide quality control support to multiple areas within both manufacturing facilities
    • Support facility improvement projects
    • Ensure management and control of critical equipment within the QC laboratories.
    • Aid in the enhancement of the Environmental Monitoring programs.
    • Oversee the implementation and continual improvement of the QC processes. Serves in a leadership role through active participation in TPP leadership team meetings.
    • Define and report on performance metrics measuring lab quality. Advises staff on areas for improvement, QC focus areas and efficiency in the quality control process.
    • Oversees the effective training of staff within the QC department. Prepare written procedures and training material.
    • Act as subject matter expert for Out of Specification investigations. Serves as lead for discussions regarding QC testing or investigations as they relate to clinical studies.
    • Responsible for personnel management of quality control associates inclusive of personnel scheduling, time management, performance management and ensuring career development opportunities in order to encourage employee retention.

    Qualifications

    Required:

    • Bachelor's Degree in the Sciences, Master's Degree Preferred. 
    • Experience working in a regulated GMP environment.
    • Minimum of 7 years working in a Quality role within a biopharmaceutical or cellular therapy organization.
    • Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
    • Ability to manage conflict.
    • Ability to work as a team member and to work collaboratively with strong listening skills. 
    • Ability to translate strategic initiatives into tactical solutions.
    • Must be knowledgeable of FDA cGMP regulations and guidelines

     

    Preferred:

    • Ability to utilize elements of Quality Risk Management to manage and control risk. 
    • Good listening skills, interpersonal savvy, and peer relations.
    • Ability to effectively present complex data and strategy to large groups.
    • Proven track record in developing or leading teams.
    • Hands on experience with flow cytometry, cell culture based functional assays (e.g. target cell killing, cytokine release, q/RT-PCR, ELISA, etc.) and/or microbial methods.
    • Expertise in 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 inclusive of DMF, IND and/or CMC.
    • Familiarity with data analysis/statistical software packages (e.g. FlowJo, Gen5, JMP, etc.) desirable, but not required.

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