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Quality Control Scientist I - Microbiology

Company: AGC Biologics
Location: Boulder
Posted on: November 23, 2022

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
Summary
We are looking for an experienced Quality Control Scientist I-Microbiology to join the AGC Biologics team. This scientist will represent QC as part of the Microbiology Technical Operations team responsible for contamination control and microbiological method development. The position will perform environmental monitoring trending, work with cross-functional teams to develop contamination control strategies and support Microbiological testing and investigations. The role will mentor and train junior laboratory personnel in microbiological method development, environmental monitoring, and contamination control.
A strong background in environmental monitoring, microbial investigations, risk assessments, microbiological support of aseptic processes and test method development is highly desired. A background in Quality Control Microbiology and contamination control related to Biopharmaceutical or pharmaceutical manufacturing is required.
Key Responsibilities

  • Represent QC on teams, prepare and present data to internal and external clients
  • Implement new laboratory testing technologies and rapid methods
  • Perform environmental monitoring data trending
  • Assist with microbial identifications and objectionable organism assessments
  • Determine antimicrobial nature of products and process steps
  • Design and author method transfers and validation studies, analyze resulting data, author and review protocol and reports in support of regulatory submissions
  • Author sample plans, test methods, and specifications to support in-process, drug substance release testing, and environmental monitoring.
  • Highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives
  • Contribute to laboratory investigations, deviations, CAPAs and analytical troubleshooting
  • Act as a subject matter expert during audits and regulatory inspections
  • Ensure QC Microbiology laboratory maintains regulatory compliance and is up to date on current industry best practices
    Knowledge, Skills And Abilities
    • Strong knowledge and experience of cGMP biopharmaceutical manufacturing, regulatory requirements, contamination control, environmental monitoring and QC Microbiological testing
    • Excellent analytical, technical writing, communication and data management skills
    • Contribute expertise in analytical methods across a wide range of technologies for the analysis of peptides/ proteins related to microbiological purity
    • Ability to analyze and risk assess complex data in support of manufacturing processes
    • Ability to understand analytical/technical data
    • Clear, concise writing skills
    • Ability to interact constructively with co-workers in a cross functional environment
      Education / Experience
      • Education: Minimum BS, but preferably an advanced degree in Microbiology, Biochemistry or other Biological Science
      • Experience: Minimum of 2+ years of hands-on experience and a Master's degree or 10+ years and a Bachelors degree in environmental monitoring, data trending, Quality Control testing and method development, such as USP bioburden, USP endotoxin testing, and compendial microbiological methods in.) in a GMP environment.
      • Experience in contamination control, sterility assurance, aseptic processes, and environmental monitoring of controlled cleanroom areas
      • Experience with relevant analytical laboratory instruments and software
        Compensation Range
        $87,416 - $104,900
        AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Keywords: AGC Biologics, Boulder , Quality Control Scientist I - Microbiology, Other , Boulder, Colorado

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