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Senior Director Process Development
3 months ago
- 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 interested
- Design 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.
