Associate Director, CMC Operations

The role

The Associate Director, CMC Operations will drive the planning and execution of programs spanning technical development, CDMO partnerships, technology transfers, and manufacturing. This role supports cross-functional Technical Operations Program Teams and manages integrated CMC timelines and departmental budgets.

What you will do

• Lead planning and execution of CMC workstreams across multiple development programs
• Build and maintain integrated CMC project plans and timelines in Smartsheet
• Lead and/or facilitate cross-functional Technical Operations Program Teams
• Coordinate activities with CDMO partners including technology transfers and manufacturing campaigns
• Identify, assess, and mitigate project risks and critical-path dependencies
• Coordinate CMC contributions to regulatory submissions
• Work with Technical Operations, Quality, Regulatory, Clinical Supply, and Finance colleagues
• Communicate project status and key issues through dashboards and governance updates
• Ensure quality, scope, and timelines are met across assigned projects
• Support departmental budget planning, forecasting, and expense tracking

Required qualifications

• 10+ years of experience in pharmaceutical drug development
• 5+ years in CMC project management or a related program management role
• Working knowledge of CMC development, technology transfer, and clinical and/or commercial manufacturing
• Experience managing work with CDMOs
• Track record of success managing multiple projects or programs simultaneously
• Advanced proficiency in Smartsheet
• Experience with project budgets, forecasting, and expense tracking
• Excellent communication, facilitation, and presentation skills
• Proven track record of creativity, problem solving, and productivity
• Demonstrated successful experience working in interdisciplinary and cross-cultural teams

Nice to have

• PMP or equivalent project management certification
• Experience supporting late-stage development and marketing application submissions (e.g., NDA Module 3)
• Bachelor’s degree in a scientific discipline
• Advanced degree

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.