Quality to the Core: A Conversation with Heather Schmidt
Drawing on more than four decades of unwavering commitment to quality and compliance, Lifecore’s Quality team plays a central role in ensuring every product meets the highest global standards. In the latest edition of our ‘Quality to the Core’ interview series, Heather Schmidt, Principal Quality Systems Specialist, discusses her team’s responsibilities, the role of audits, […]
Quality to the Core: A Conversation with Jessica Raddatz Hensley
Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices and combination products, Lifecore has a strong, 40+ year global regulatory track record. We recently spoke with Jessica Raddatz Hensley, Director of Quality Control (QC) who explained the work that QC scientists do, the technological advancements […]
Quality to the Core: A Conversation with Andy Burnes
Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global regulatory track record. We recently spoke with Andy Burnes, Senior Microbiologist and Environmental Monitoring Lead. After nearly seven years at Lifecore—including time in both QC Microbiology […]
Quality to the Core: A Conversation with Jackie Klecker
With more than 40 years of regulatory excellence, Lifecore continues to set the standard for quality in injectable pharmaceutical and medical device manufacturing. We recently sat down with Jackie Klecker, Executive Vice President, Quality & Development Services, to learn more about the quality function at Lifecore, the leadership attributes needed to thrive in this function, […]
Quality to the Core: A Conversation with Patrick Curran
Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global quality and regulatory track record. The Warehouse organization plays a critical but often unseen role in product quality and safety. Storage conditions, system controls, documentation, and […]
Quality to the Core: A Conversation with Jeremy Huotari
Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global quality and regulatory track record. Quality in pharma manufacturing isn’t just about procedures or training—it is built into the very spaces where work happens. Cleanroom design […]
Quality to the Core: A Conversation with Mike Puzak
Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global quality and regulatory track record. From utility systems and air handling units to pest control and emergency power redundancy, the work of Lifecore’s Facilities Management organization […]
Quality to the Core: A Conversation with Melissa Seaver
Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global regulatory track record. We recently spoke with Melissa Seaver, Director of Fermentation, Sanitization, and Manufacturing Compliance. With nearly 29 years at Lifecore, Melissa offers a ground-level […]
3 Pharmaceutical Trends Facing CDMOs in 2022
There are several trends set to influence the pharmaceutical sector in 2022. Many CDMOs, including Lifecore, have already begun adapting by expanding their capacity and cold chain offerings in anticipation. In this article, we explore the following biotech industry trends and how CDMOs can keep up. Demand for fill-finish services for injectables New players entering […]