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Associate Director, CMC Operations

Kailera Therapeutics

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Location:
United States, San Diego

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

160000.00 - 200000.00 USD / Year

Job Description:

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
  • Monthly wellness stipend
  • Generous 401(k) match
  • Disability and life insurance

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
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