Executive Director, Process Development and Controls in Newton, MA



$250K - $500K


Process Management, Operations Management


15+ years

Job Description

Position Title: Executive Director, Process Development and Controls Position Summary:

We are seeking a seasoned professional with strong collaboration skills to provide technical and strategic leadership of key CMC operations to successfully pioneer the application of small molecule therapeutics in mitochondrial disorders. Reporting to our VP, Pharmaceutical Sciences and Technical Operations, the ideal candidate will develop phase-appropriate drug substance manufacturing processes, analytical methods, and quality controls for small organic and peptide drug candidates. With a lead peptide candidate advancing through Phase 3 trials and a pipeline of compounds either in or approaching clinical development, responsibilities in both analytical and process chemistry span from research to registration, including required GMP-compliant development activities, technology transfers, process and method validations, and commercial API manufacturing and c

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Valid through: 2020-1-20

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