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Reporting to the Senior Director, CMC Operations, the Associate Director, CMC Operations will manage the flawless execution of Kailera’s CMC activities, spanning departmental financial management, alliance management with CDMO partners, technical development work, technology transfers, manufacturing, and preparation of regulatory submissions. In collaboration with CMC core team representatives, the individual will support cross-functional CMC sub-teams to manage all technical activities for Kailera’s multiple development projects. The Associate Director will also establish preparation and monitoring of departmental budgets.
Job Responsibility:
Support execution of CMC-related projects, culminating in the successful preparation of regulatory submissions and product approvals
Actively support Tech Ops strategies and goals by participating in and/or leading cross-functional CMC sub-teams
Work closely and collaboratively with Tech Ops, Quality, Regulatory, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management activities
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members
Ensure quality, quantity, and timelines in all assigned projects
Update team members on project target dates and priorities
Proactively contributes to budget forecasts and tracking expenses
Requirements:
10+ years of experience in pharmaceutical drug development, clinical and/or commercial manufacturing familiarity, and track record of success supporting multiple projects or programs simultaneously
Excellent communication/presentation skills and proficiency in Smartsheet software
Proven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place
Demonstrated successful experience with working in interdisciplinary and cross-cultural teams
Bachelor’s degree in a scientific discipline preferred
What we offer:
Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
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