Jeffrey Eckert Email & Phone Number

New York City Metropolitan Area

Cambridge, Ma, Us

Led the Pharmaceutical Development group since September 2023 covering all aspects of drug substance, drug product, and analytical development for Sage's early-phase pipeline.

The Woodlands, Tx, Us

Summit, New Jersey, Us

• Oversee GMP drug substance manufacturing activities conducted at Contract Manufacturing Organizationso Establish starting material specificationso Design optimized processes for intermediates and final drug substanceso Evaluate the commercial readiness of late stage drug substance collaborationso Work with development colleagues to identify commercializable routes of synthesiso Collaborate on cross-functional teams (analytical, drug product, regulatory, etc.) to establish compound specific development strategieso Compiled annual budget plans to secure funding for project activities• Contribute drug substance sections to regulatory documentso Authored drug substance development and manufacturing sections for IND/IMPD to support clinical studieso Authored drug substance development and manufacturing sections for NDA/MAA approvalso As a key subject matter expert, attend meetings with regulatory agencies (FDA, EMA) to address concerns and answer questions on filing information• Coordinated CMC meetings and interacted with global project teams

• Served as drug substance representative on product development teams• Secured funding for and planned and executed manufacturing campaign to generate material to support Phase II clinical studies• Coordinated departmental seminars from visiting professors• Team member for initiative to increase efficiency within the department• Supervised a research group of one Senior Scientist (Ph.D. level) and one to two Assistant/Associate/Scientist I (BS/MS level)• Supervised the technology transfer of a complex multi-step process to a commercial manufacturing site• Coordinated project resources for the outsourcing of a novel excipient including contributing to the CMC section of the IND• Served as subject matter expert for the Pharmaceutical Sciences Change Management System and entered appropriate information into the Trackwise database• Departmental coordinator for BS/MS recruiting efforts• Developed practical scaleable processes for pharmaceutical intermediates and drug substances• Analyzed complex reaction mixtures by HPLC, 1H NMR, and TLC• Developed crystallization/precipitation techniques for purification to replace column chromatography• Scaled up chemical processes in both the pilot plant and medium scale production facilities to deliver materials for preclinical and clinical studies.• Studied reaction mechanisms of chemical processes using in situ FTIR (ReactIR) technology.

Kenilworth, New Jersey, Us

Updated as a result of the recent merger between Schering-Plough and Merck. Please see above for description of responsibilities and accomplishments.

Ph.D., Synthetic Organic Chemistry

Bs, Chemistry