Associate Director - Process Development, Chemistry
2 days ago
Description
• Prilenia Therapeutics develops therapies for neurodegenerative diseases. • The Associate Director will oversee DS GMP production activities.
Requirements
• M.Sc. in Organic Chemistry, PhD preferred • 7+ years’ experience in Chemical Research & Development and Commercial product manufacturing in GMP environment • Demonstrated track record of working with CMOs in line with contractual deliverables within timelines and budgets • Experience in multi-step chemical process development and manufacturing, including process parametrization, validation and scale-up • Experience with regulated industry Product Development and Regulatory requirements (knowledge of FDA and EMA requirements e.g., cGMP and marketing applications, and ICH guidance affecting drug substance development (ICH Q1 to ICH Q13) • Working and theoretical knowledge of manufacturing, processing and testing equipment • Demonstrated experience with regulatory submissions in various markets with emphasis on marketing authorization, post-marketing and late stage development
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