Sterility Assurance Manager
Today, 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 is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
As Sterility Assurance Manager, you are responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Bioscience and Cell Therapy Operations Departments. Individual should be able to work independently with little direction to review policies and procedures and related completed media fill 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 Bioscience Media and LAL Operations and Cell Therapy Operations Management and QA leadership. Primary responsibility is to maintain sterility assurance for LAL products, Aseptic Media Products and Cell Therapy Products.
- Provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for Cell Therapy and Bioscience production processes from incoming raw materials through final product release.
- Provide oversight and sterility assurance expertise to Bioscience and Cell Therapy Operations to assure aseptic processing meets US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1, ”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820). Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
- Provides microbiological expertise to support EENs, deviations, CAPAs and Complaints related to aseptic processing.
- Supports 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 protocols, validations and specifications.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Quality Responsibility
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates
- Bachelor’s or master’s degree in microbiology required.
- Extensive GMP experience in the biologics industry, with solid direct QA experience with team management experience.
- Working knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room management, quality control endotoxin testing and microbiological control strategy required.
- Solid experience with oversight of aseptic processing and the associated international aseptic processing regulations is required. Experience in cell culture, cell or gene therapy experience is a plus.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic. The ability to interface and communicate directly with clients may be required.
- Strong collaboration and communication skills required. Ability to multitask and adequate sense of urgency a must.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.