Sterility Assurance Manager - Cell Therapy
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.
Responsible for QA oversight of Aseptic Processing Program , Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations. 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, including viral vector products
- Provide strategic plan and expertise for the development and implementation of the site Microbial Control Strategy.
- Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.
- May manage a staff of 1 -2 specialists or provide guidance, oversight and support for Operations and QA/QC specialists
- Provide oversight and sterility assurance expertise to 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).
- Assess 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 assure the quality of aseptic processes
- Provide 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 the drafting and review of cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications.
- Bachelor’s or master’s degree in microbiology required.
- Substantial GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience.
- Management experience desired.
- Working knowledge of microbiological and sterility testing, media fills, environmental monitoring , clean room qualification and management, quality control endotoxin testing and microbiological control strategy required.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required. Experience in cell culture, cell or gene therapy experience is a plus.
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 and/or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred. Working Knowledge of endotoxin testing required.
- Knowledge and understanding of USP and EP, endotoxin, and sterility testing,
- 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.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
- 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.
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.