Associate Director, Manufacturing
July 24
🏢 In-office - Bay Area
Description
• Manage and oversee small molecule, solid oral dosage Drug Product manufacturing activities at Contract Manufacturing Organizations (CMOs) to support late-phase clinical programs and commercial supply. Act as company liaison and point of contact for CMOs, as well as provide person-in-plant support to oversee critical manufacturing activities as needed • Lead process development, process validation, manufacturing, technology transfer, troubleshooting of manufacturing process issues, investigations and resolution of deviations as Drug Product transitions from Phase 2 to Phase 3 and validation at CMOs • Design, implement, analyze, and author protocols and reports for Proven Acceptable Range study experiments to optimize manufacturing processes. Collate manufacturing process data to develop metrics, control charts and reports to improve manufacturing processes • Assist with Supply Chain, Analytical, and Stability activities as needed • Review/approve documents associated with Drug Product development and manufacturing, such as change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System. • Collaborate with cross-functional teams as follows: • Supply Chain: Work with Supply Chain team at Corcept and CMO to ensure manufacturing schedules and forecasts are aligned to meet corporate needs, prepare requests for proposals and statements of works, and identify risks that may critically affect supply and escalate to management as needed. • Analytical: Work with the Analytical team at Corcept to provide manufacturing input for analytical or stability related issues. • Quality: Work with Quality organization at Corcept and CMO to ensure cGMP standards are met, investigation/deviations are closed in a timely manner, and facilitate batch release
Requirements
• Expertise in late stage process development, process validation, commercial manufacturing, and technology transfer of small molecule, solid oral dosage Drug Product • Familiar with Quality Risk Assessment, Design of Experiments, Proven Acceptable Range studies, and application in late stage CMC development • In-depth working knowledge of US and EU regulatory requirements for cGMPs • Expertise in managing CMOs for late-stage development and commercial manufacturing programs • Experience with drafting regulatory submissions such as IND, IMPD, NDA and MAA preferred • Strong leadership and project management skills with the ability to manage multiple technical projects successfully • Proficient in critical thinking, analyzing technical data, and preparing written technical reports
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