Biologics Associate II/III

Company: Fred Hutchinson Cancer Research Center
Location: Seattle
Posted on: September 24, 2022

Job Description:

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 Biologics Associate II/III is responsible for all aspects of Biologics GMP and development material product production, from cell culture scale up through production in bioreactors (or other technologies) to product purification and bulk fill. Products include biological therapeutics such as monoclonal antibodies, plasmids and viral vectors for clinical and research use.
Responsibilities

• 
  
• Plan for and execute GMP manufacturing operations per the production schedule.
  
• Scale up of cell culture and purification procedures from development to production levels
  
• Assist in the development of purification schema appropriate to each product
  
• Adapt alternative technologies to support production activities
  
• Train and mentor junior personnel, including cross training to provide backup capabilities
  
• Create or revise documentation for GMP operations, including batch records and standard operating procedures
  
• Initiate and investigate deviations and assist in development of CAPA.
  
• Support timely closure of deviation reports and CAPA
  
• Support the improvement and implementation of all GMP procedures and policies related to manufacturing operations
  
• Monitor and maintain equipment including autoclaves, bioreactors, incubators and chromatography equipment
  
• Assist with facility cleaning, culture vessel de-pyrogenation, assembly and sterilization
  
• Interface with and assist Quality Control in coordinating sample submission for product testing and facility monitoring
  
• Demonstrate technical acumen, operational understanding and GMP compliance in the maintenance of the Biologics Processing Facility.
  
• Maintain a high level of quality and safety standards.
  
• Analyze and evaluate the effectiveness of manufacturing methods, costs and results.
  
• Maintains appropriate level of training and meets compliance standards.
  
• Evening and/or work may occasionally be required based on project need.
  
  Qualifications
  Minimum Qualifications Biologics Associate II:
  
  • 
    
  • Bachelor's degree in Biology, Chemistry or related scientific major or equivalent.
    
  • 1-2 years of experience in a biologics production facility or equivalent.
    
  • Experience in aseptic processing techniques.
    
  • Experience with clinical GMP product production with a thorough understanding of cGMP requirements for clinical manufacturing.
    
  • Cell culture expansion experience.
    
  • Experience with process equipment such as bioreactors and/or chromatography equipment.
    
  • Excellent communication skills, both oral and written.
    
  • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    
  • Must be able to don and wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE).
    
  • Must have the ability to lift a minimum of 25 pounds, the ability to stand for extended periods and use stepladders.
    
  • Must have the ability to stand for long periods.
    
    Minimum Qualifications Biologics Associate III:
    
    • 
      
    • Bachelor's degree in Biology, Chemistry or related scientific major or equivalent.
      
    • 3-5 years of experience in a biologics production facility or equivalent.
      
    • Robust experience in aseptic processing techniques.
      
    • Experience with clinical GMP product production with a thorough understanding of cGMP requirements for clinical manufacturing.
      
    • Cell culture expansion experience.
      
    • Experience with process equipment such as bioreactors and/or chromatography equipment.
      
    • Ability to work with limited supervision and troubleshoot and investigate operational issues.
      
    • Excellent communication skills, both oral and written.
      
    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
      
    • Must be able to don and wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE).
      
    • Must have the ability to lift a minimum of 25 pounds, the ability to stand for extended periods and use stepladders.
      
    • Must have the ability to stand for long periods.
      
      Preferred Qualifications:
      
      • 
        
      • Experience with protein purification.
        
      • Familiarity with multiple technologies for culture of mammalian and prokaryotic (bacterial cell culture; fermentation) cells at various scales of production.
        
      • Experience with DNA plasmid prep and viral vector production.
        
      • High level of comfort in dealing with specialized mechanical and electronic equipment.
        
      • Familiarity with disposable technologies such as Single Use Bioreactors (SUB).
        
        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 DiversityWe 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.

Keywords: Fred Hutchinson Cancer Research Center, Seattle , Biologics Associate II/III, Other , Seattle, Washington