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Associate Director, CMC Operations

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Kailera Therapeutics

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Location:
United States , Waltham

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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
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Job Description:

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. Support cross-functional CMC sub-teams to manage all technical activities for Kailera’s multiple development projects. 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 coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • equity grants

Additional Information:

Job Posted:
January 15, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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