Sterility Assurance Manager

Company: Lonza Group Ltd.
Location: Houston
Posted on: October 22, 2024

Job Description:

Sterility Assurance ManagerToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.Lonza Houston, TX facility is looking for a Sterility Assurance Manager for Quality Assurance. In this role you will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations. This individual should be able to work independently with little direction to review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures. Review of sterile filter validations, integrity testing and procedures is also required. The individual is expected to interact with Cell and Viral Therapy Operations Management, QC and QA leadership. Primary responsibility is to maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products.Key responsibilities:

• Provide strategic plan and expertise for the development and implementation of the site Sterility Assurance Program.
• Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.
• Lead Sterility Assurance Council.
• Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements.
• Assess facility and quality systems' state of compliance with internal requirements and appropriate regulations and participate in the development of action plans to correct deficiencies and improve quality processes.
• Provide microbiological expertise to support EENs, deviations, CAPAs and complaints related to aseptic processing.
• Support regulatory and client audits as Aseptic Sterility Assurance subject matter expert.
• Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications.
• Provide guidance, oversight and support for Operations and QA/QC specialists.Key requirements:
  • Bachelor's Degree in Life Sciences.
  • Experience with regulations (US, EU and other).
  • Highly experienced in Biopharmaceutical manufacturing and/or aseptic processing working in a GMP environment.
  • Advanced experience in Aseptic Processing.Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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Keywords: Lonza Group Ltd., Port Arthur , Sterility Assurance Manager, Executive , Houston, Texas