Dr Chantal Felten has over 10 years of experience in Biopharmaceutical Product Development, with 7 years as a senior scientist/group leader in Genentech’s Quality and Process Development departments.
During her time at GNE as a group leader/senior scientist, she has lead clinical development teams on key CMC activities and has supported regulatory filings for both clinical and commercial antibody drug therapies.
As a technical expert in analytical product release testing and characterization, Dr Felten lead the Early Stage (Phase I/II) as well as the Late Stage (Phase III to post commercial) validation functions. In addition, she managed the global commercial method transfer and troubleshooting function and oversaw analytical characterization efforts.
Upon leaving GNE in 2007, Dr Felten joined Cardiome Pharma Corp as head of Biologics Pharmaceutical Analysis. In this position she guided all CMC activities related to the drug substance and drug product release and characterization for a complex biological.
Dr Felten is an accomplished project manager and has extensive practice in auditing CMO and partner manufacturing and testing facilities. She is an expert in application of ICH guidelines and ISO guidance’s to the drug development process.
In 2008, Dr Felten founded Alpine Analytical Academy, which provides CMC consulting and customized in depth training solutions to large and small biopharma, around the world with clients located in Canada, the US, China and Europe.
She holds a Masters in Chemistry and PhD in Analytical Chemistry from Universitaet des Saarlandes, Saarbruecken, Germany, followed by post doctoral work at Northeastern University, Boston, MA where she was involved in the development of new technologies and methods development for CE-MS characterization of proteins and small molecules.
Fluency: English, French and German both spoken and written.