KaileraHiring

Associate Director, CMC Operations

  • Remote, United States
  • Full-time
  • Lead
  • Posted 10 days ago
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In one line

Program role in technical operations for a clinical-stage drug developer, planning CMC work across several programs; hub-based a few days a week or mostly remote with periodic hub visits.

About the role

The work covers technical development, CDMO partnerships, tech transfers and manufacturing through to regulatory filing, coordinated across several development programs at once.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Employment
Full-time
Skills
CMC project management, Technology transfer, Smartsheet, Regulatory submissions
Posted
19 Oct 2026
Last checked
29 Oct 2026

What you will do

  • Plan and run CMC workstreams from technical development through filing and approval
  • Keep integrated CMC plans and timelines in Smartsheet across drug substance, product, analytical, packaging and supply
  • Run cross-functional program meetings: agendas, decisions, actions, risks and issues
  • Track CDMO deliverables for tech transfers and manufacturing campaigns against contracted scope
  • Coordinate CMC input to regulatory submissions and help with departmental budget forecasting

What they look for

  • Ten or more years in pharmaceutical drug development, with five plus in CMC or program management
  • Working knowledge of CMC development, tech transfer and clinical or commercial manufacturing
  • Experience managing work with CDMOs
  • A record of running several projects or programs at the same time

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Questions about this job

Is this job fully remote, and from where?

Yes. The posting lists Associate Director, CMC Operations as a remote role for candidates in the United States.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a lead role. The posting asks for: ten or more years in pharmaceutical drug development, with five plus in CMC or program management; working knowledge of CMC development, tech transfer and clinical or commercial manufacturing; experience managing work with CDMOs. Skills it names include CMC project management, Technology transfer, Smartsheet, Regulatory submissions.

How do I apply with Keywordise AI?

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