Director, Process Chemistry

Description

The purpose of this role is to?provide leadership and Subject Matter Expertise (SME) in the area of process chemistry. The Director, Process Chemistry will support the Phlow's CDMO business to ensure business objectives are met. Serve as the technical leader for the API development projects and oversee and manage Phlow's partners. The candidate will ensure excellence of our process development and technical transfer to Phlow's partners and interact with other internal and external Phlow departments (EH&S, Operations, Program Management, Quality Assurance, Regulatory Affairs, Commercial, Finance) as required. The candidate will personify Phlow's shared values and culture, both internally and externally. The candidate?will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues

Requirements

• Provide leadership to Phlow's process development projects for small molecule APIs, key intermediates or related materials
• Ensure that projects meet all deliverables including budgets and timelines
• Provide excellent support to Phlow's US government business
• Provide excellent support to Phlow's commercial business
• Provide process chemistry subject matter expertise on other Phlow projects
• Ensure efficient technology transfers
• Evaluate new projects with the department to identify synthetic routes for process development that deliver scalable, cost-competitive manufacturing process that are ready for technology transfer to manufacturing partners for internal projects.
• Conduct literature searches and laboratory work to identify potential synthetic routes and propose optimal routes for evaluation and development.
• Review, author and approve documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc.
• Participate in the ongoing continuous improvements in manufacturing processes resulting in improving product quality, robustness, and cost.
• Manage multiple projects / workstreams and make sound and timely decisions based on business priorities.
• Collaborate with Analytical Chemistry, EH&S, Operations, Project Management, Quality Assurance, Regulatory Affairs, Commercial, Finance to ensure strong working relationships with all partners and Phlow employees.?

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