Mark Roberge has been a leader in cGMP QC, QA, Process Development, and Operations for the last 18 years. Following post-doctoral studies, Mark entered the Quality Control laboratory in a parenteral CMO, leading teams in raw material, finished good and stability testing. This provided an array of experience in development, verification, transfer and validation of compendial, and client sponsored analytical methods.

Mark transitioned from QC to a role in operations, managing a group focused on the technical transfer of client manufacturing methods. Working with clients to define specifications, equipment, processes and documentation allowed for experience with a diverse range of approaches to solving pharmaceutical manufacturing challenges. The array of liquid and lyophilized products transferred included those intended for the US market as well as the EU, Japan, and other regions. At this time Mark was also responsible for a group tasked with administering training to manufacturing technicians and for managing high-profile and high-impact deviation investigations. Quality has always been Mark’s passion, so when he had the opportunity to step into leading a process development group for one of the worlds largest allergy immunotherapy manufacturers he saw this as an opening to adopt QbD principles into the earliest stages of source material and API manufacturing, thereby avoiding the risks he saw so many of the tech transfer clients accepting with a traditional approach to development.

Moving back to a CMO, he spent nearly two years managing a visual inspection group, as the industry matured and developed manual visual inspection criteria. Provided with the ability to interact with each client and their specific interpretation of the industry standards provided an opportunity to see how different approaches could be used to protect patients and satisfy the regulatory authorities. He also oversaw change control at the facility and rolled out a digital change control system. He then chose to embark on the design and construction of an aseptic fill finish CMO facility. As the second employee of the company, Mark played a major role in facility design such as compounding and filling suite design, material flows, and personnel flows, as well as less tangible aspects that included systems such as quality, validation, and inventory management.