Director, Chemical DevelopmentIrvine, California, United States

Director, Chemical Development

The Director, Chemical Development will provide leadership in strategic planning and execution of CMC activities related to drug substance development and manufacturing at CMO's from Phase 1 through commercialization. They will also collaborate closely with the Technical Operations, Pharmaceutical Sciences, Analytical Development and Supply Chain teams to ensure continuous supply of clinical trial and commercial products.

Let's talk about some of the key responsibilities of the role :

• Lead API operations across multiple CMC programs and ensure that operational plans are consistent with overall regulatory and corporate strategies. Lead all aspects of the manufacture of clinical and commercial drug substance production at CMOs and ensures adherence to project timelines to support clinical and commercial supply, in line with business objectives. Establish and manage relationship with CMOs.
• Collaborate with CMOs to develop and lead manufacturing initiatives including, but not limited to : CMO site selection, technology transfer, scale-up, process development and optimization, validation, clinical and commercial production.
• Develop strategies to ensure that supply chains for clinical and commercial drug substance are robust. Create risk mitigation plans to ensure timelines CMC activities are consistent with overall development timelines.
• Collaborate with other internal functional groups to ensure that manufacturing activities comply with cGMPs and regulatory filings. Facilitate the resolution of deviations in a timely manner.
• Develop and manage budget for CMC programs. Collaborate with Finance to address budget variance.
• Collaborate with Regulatory Science to set CMC strategies. Author CMC regulatory submissions.
• Collaborate with Pharmaceutical Sciences to set strategies for drug substance development
• Review / approve drug substance manufacturing batch records, protocols, specifications and deviations.
• Manage Person-in-Plant coverage to provide adequate oversight for manufacturing activities.

Factors for Success :

A Few Other Details Worth Mentioning :

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $163,500 - $228,900 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.