Senior Director Process Development

3 weeks ago


Cambridge, Massachusetts, United States Meet Full time

Meet has partnered with a Cambridge biotech leading in cell therapy treatments in the ophthalmology space.Our client recently received regulatory approval for one of their products overseas and is looking to replicate this in the US. They are seeking a tenured Senior Director of Process Development to join their growing team and support the development of their assets.This role is onsite at their Cambridge location, and our client offers a competitive relocation package to those interestedDesign and execute detailed experiments to comprehend Drug Substance and Drug Product processes, establishing robust, integrated process control strategies.Support regulatory strategies and activities, including authorship and review of CMC documentation for regulatory submissions.Assist in the development of standard operating procedures, FMEA, batch records, and analytical sampling plans.PhD in life sciences or engineering, with over 10 years of pertinent industry experience.Robust cell therapy experience required - preferably Allogenic and late stage.



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