Senior Director, Process Chemistry

Role Summary

The Senior Director, Process Chemistry will lead small-molecule process development and manufacturing efforts for clinical-stage and commercial Drug Substances. The role includes developing outsourcing strategies, coordinating DS activities with cross-functional CMC teams, and preparing DS content for regulatory submissions. It will also involve supervising staff and representing the DS function on cross-functional teams.

Responsibilities

• Lead all Drug Substance (DS) efforts, including process development as well as the manufacture of DS for clinical and commercial purposes
• Develop outsourcing strategies and relationships to support all aspects of DS development and manufacturing
• Develop and lead the successful execution of phase-appropriate DS project plans; prepare RFPs and assist in selecting vendors
• Lead the preparation of the DS sections of various regulatory documents (IND, NDA, etc.)
• Effectively integrate DS activities with those of sister CMC functions, including Pharmaceutics, Analytical Development, Quality Assurance, and Regulatory Affairs
• Supervise internal and external technical staff as needed to ensure effective execution of activities and attainment of goals
• Integrate DS activities with those of other corporate functions, including legal, finance, and HR
• Effectively and professionally represent the Process Chemistry function, and when needed the broader CMC function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners

Qualifications

• Ph.D. in organic chemistry, chemical engineering, or related discipline with 12 - 15 years of industry experience or equivalent experience
• Strong experience required in small molecule process development
• Experience supporting DS for different drug product types is desirable
• Experience working in close collaboration with technical, regulatory, quality, clinical, project management, and supply chain functions, in a cGMP operational environment
• Experience in leading and managing outsourced development and manufacturing efforts and associated operating budgets
• Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
• Demonstrated track record of setting priorities, meeting timelines, motivating others, and managing budgets
• Superb communication skills and the ability to shape, frame, and present to diverse internal and external audiences are required

Additional Requirements

• Periodic travel to manufacturing and other partner sites is required (approximately 10-20% of time).