About This Role  

Biogen is seeking a motivated and creative chemist to join our small molecule development team in Cambridge, MA. This individual will bring a strong small molecule chemistry development background and will define and execute on a strategy for synthetic route design, process optimization, vendor site technology transfer, scale-up and validation of Biogen’s small molecule programs from pre-clinical to clinical stages of development. 

What You’ll Do  

• Work closely with analytical chemists, chemical engineers and formulation scientists to understand/improve processes by applying fundamental process chemistry principles.
• Make valuable contributions to the selection of API and starting material synthetic routes.
• Establish and oversee phase appropriate process development plans for drug substance.
• Prepare technical reports, patent application content, publications, and oral presentations.
• Define regulatory strategies and design DoE studies to determine critical process parameters (CPP).
• Provide updates to technical and asset teams and work collaboratively with other development functions (formulation development, analytical development, external manufacturing, quality, regulatory and supply chain) to ensure alignment in the planning and execution of development activities.
• Influence CDMO selection and provide oversight to external process development team(s).
• Manage junior level chemists.
• Inform selection of capital purchases.

Who You Are  

You love small molecule chemistry development and are passionate about interacting with various functions and partners to develop small molecule therapeutics and to advance Biogen’s pipeline. You love learning new technological skills and working through collaboration.

Required Education and Experience

• Ph.D. in Synthetic Organic Chemistry or closely related field with 4-5 years of relevant experience in small molecule chemical process development
• Master's degree in scientific discipline with 8-10 years of relevant experience in small molecule chemical process development

Required Skills  

• Track record of successfully managing teams and contracted CDMO contracts.
• Working knowledge of cGMP protocols, ICH guidelines related to cGMP, technology transfers, manufacturing record review and approval.
• Drug substance development experience in advancing programs from pre-clinical to late clinical phases of development and experience in the preparation of regulatory filings.
• Excellent written and oral communication skills and demonstrated ability to work effectively in a team environment.

Preferred Skills 

Prior experience in enabling technologies (Catalysis, Biocatalysis, Flow Chemistry) is preferred.

Why Biogen?  

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.