Associate Director/Director, Downstream Process Development, 1055016
Job Scope & Purpose:
Our Boston-area clinical development client seeks an exceptional Associate Director/Director to play a leadership role for its Process Development and Manufacturing needs. The ideal candidate will have substantial downstream process development and manufacturing experience with biologics, and will have technical oversight and management of downstream process activities for the development, validation and manufacturing of monoclonal antibodies. Contact Kevin Rees to learn more.
Primary Job Responsibilities:
• Manage downstream process development, optimization, validation and manufacturing initiatives at external manufacturing partners for clinical supply through BLA filing and launch, including purification, formulation and fill/finish
• Author validation protocols/reports and batch records in collaboration with CDMO partners
• Manage supply/demand forecasting, operational budgets and timelines
• Oversee trending of process development and manufacturing data for continuous process improvements
• Work with partners in quality for batch release, including review of data and batch records
• Author relevant sections of regulatory filings
Primary Job Requirements:
• BS/MS/PhD with at least 7-10 years relevant experience, with at least two in a leadership role.
• Extensive experience with the manufacturing of monoclonal antibodies
• Willingness to work, and successful prior work experience, within a virtual environment
• Previous validation experience in support of late stage clinical programs preferred
• Experience with fill/finish preferred
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