Associate Director/Director Process Chemistry

The Associate Director, Process Chemistry will be responsible for supporting drug substance related activities, both externally and internally. They will interface directly with CROs, CDMOs and others to execute on-time delivery and ensure phase appropriate process procedures are followed. Internally, they will interface with both CMC and members of other departments to effectively execute their drug substance project needs.

• →Oversee contract development and manufacturing organizations (CDMOs) to Process Chemistry activities for drug substance (DS) with a focus on late stage and validation, working across both International and US based CDMO’s. Additionally, provide on-site technical support at CDMO’s on an as-needed basis to oversee various manufacturing/scale-up/validation activities and provide technical expertise to troubleshoot manufacturing/packaging process issues
• →Author and manage request for proposal documents to initiate work at CDMO’s
• →Support and author DS content for CMC Regulatory for US and Rest of World with focus on late-stage development and marketing applications
• →Support Quality Assurance audits, on site at CDMO’s or remotely, as a technical subject matter expert, as needed
• →Proactively interface effectively with other CMC team members (e.g., Analytical Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)
• →Regularly and clearly communicate Process Chemistry both verbally and in visual presentation form, efficiently and contextually

This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

• PhD. in Organic Chemistry from Purdue University
• 7+ years as a process chemist in industry
• Experience leading route scouting, process development, scale-up, DOE, process validation, and CMC strategies for small molecule drug substances
• Additional experience with authoring and reviewing regulatory documents, including INDs, NDAs, MAAs, CBE30, and Type II submissions.