Matthew Spaits Email & Phone Number

Somerville, Massachusetts, United States

Durham, North Carolina, United States

• Managed commercial scale production of GreenLight’s mRNA based COVID-19 vaccine, delivering successful batch execution to meet key company milestone• Facilitated cross functional coordination within the CMC organization while driving toward completion of key company milestones including CMC infrastructure initiatives and process characterization of mRNA manufacturing platform

Cambridge, Massachusetts, United States

• Managed and tracked progress of Acceleron’s early and late-stage discovery portfolio in accordance with the company’s stage gate and governance structure• Facilitated cross functional integration between functional groups: R&D, Nonclinical Development, Clinical Sciences, Clinical Pharmacology, Corporate Strategy, CMC, and Regulatory, to drive toward stage gate transitions and advancing early pipeline

Cambridge, Ma

• Served as Project Manager for Sotatercept drug substance production and validation at contract manufacturing organization with progression through tech transfer, phase III clinical production, process characterization, process validation, commercial production, and BLA authoring• Delivered complete and scalable processes for the downstream manufacturing of highly glycosylated CHO cell derived Fc-fusion proteins based on a single use disposable manufacturing platform with contributions to over ten programs including Reblozyl®• Managed Acceleron’s viral clearance program from 2013 to 2021; running IND enabling studies at multiple independent contract labs