Helge R.
About Helge R.
Helge R. is the Vice President of Drug Substance Process Development at Fulcrum Therapeutics, bringing extensive experience in chemical process development and technology transfer from his previous roles at various pharmaceutical companies.
Work at Fulcrum
Currently, Helge R. serves as the Vice President of Drug Substance Process Development at Fulcrum Therapeutics. He has held this position since 2022, working in South Plainfield, New Jersey. In this role, he focuses on overseeing the development and optimization of drug substance processes, ensuring alignment with the company's strategic goals.
Previous Experience in Pharmaceutical Industry
Helge R. has extensive experience in the pharmaceutical sector. He worked at PTC Therapeutics, Inc. as Vice President of Technical Operations - Small Molecules from 2020 to 2022. Prior to that, he held the position of Senior Director, Head of Small Molecule Chemical Development at Shire Pharmaceuticals from 2014 to 2019. His career also includes a role as Senior Manager in Chemical Process R&D at Purdue Pharma L.P. from 2007 to 2014.
Education and Expertise
Helge R. earned a Doctor of Philosophy in Synthetic Organic Chemistry from Johannes Gutenberg University Mainz in Germany. He also holds a Master of Science in Chemical Engineering from FH Fresenius in Wiesbaden, Germany. His educational background supports his extensive expertise in drug development and process optimization.
Regulatory Filings and Approvals
Helge R. possesses a strong track record in managing successful regulatory filings and approvals across multiple regions, including the United States, European Union, and other countries. His experience includes ensuring compliance with regulatory standards and facilitating the approval process for various pharmaceutical products.
Technology Transfer and CMC Management
Helge R. has demonstrated proficiency in technology transfer to commercial production sites, ensuring a seamless transition from development to manufacturing. He has managed both internal Chemistry, Manufacturing, and Controls (CMC) functions and external CMC activities at contract manufacturing organizations, showcasing his ability to develop and manage strategic partnerships.