Responsibilities

• Develop chemical processes for manufacturing drug substances
• Manage and mentor process chemists internally and at contract manufacturers (CMOs)
• Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
• Contribute to the development of target drug substance profiles and specifications, setting goals and maintaining timelines for CMO manufacturing activities
• Ensure quality, economics, and adequate supply chain security for drug substances
• Contribute to identifying and facilitating purchase of custom raw materials and supplies needed for drug substance manufacturing under tight time constraints
• Develop and maintain good relationships and contracts with CMOs
• Visit, evaluate and audit contract sites for GMP manufacturing activities
• Coordinate production schedules based on preclinical and clinical development requirements
• Review proposals, negotiate prices, recommend suppliers, verify delivery, and maintain necessary records
• Work cross functionally with CMC analytical team and formulations team, QA and Regulatory teams
• Work collaboratively with partners for all drug substance related activities
• Compile documentation and draft CMC sections for regulatory submissions
• Support interdisciplinary working teams with recommendations, advice and action plans for drug substance related issues
• Represent the drug substance team in cross-functional working teams, and communicate drug substance related issues and information to groups within the company

Qualifications

• Ph.D. in Chemistry
• Strong synthetic organic chemistry knowledge and problem solving skills
• Strong understanding of solid state properties of small molecules
• 8+ years of experience in small molecule drug substance development
• Direct experience with management of CMOs
• In depth understanding and knowledge of industry practices in drug substance manufacturing and supply
• In depth knowledge of cGMP regulations and compliance
• Good understanding and knowledge of analytical methods and related issues
• Experience in writing CMC sections for Regulatory submissions
• Strong understanding of drug development process from R&D through commercialization
• Strong written and verbal communication skills
• Strong organizational skills and ability to effectively manage multiple priorities and projects
• Ability to travel domestically and internationally