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AbbViePosted 1 month ago

Director, ADC CMC Sciences

$160,500–$305,000 year

HybridWaltham, Massachusetts, United States

Full TimeSenior LevelDoctorate Or Professional DegreeEnterprise

Job Summary

Lead cross-functional S&T product teams and coordinate governance efforts, including product performance teams and gate reviews, for commercial and pipeline small molecule products. Develop comprehensive project plans, budgets, and timelines spanning technical projects from phase II through commercialization. Ensure proactive technical ownership of product, process, and methods while facilitating issue resolution with strategic operational impact. Present technical information regarding manufacturing processes and methods to management and regulatory agencies. Review submissions through registration and post-approval life-cycle management, serving as a peer or management reviewer. Represent projects on the multidisciplinary Product Presentation and Device Strategy Team, collaborating with R&D, RA, and Operations functions. Manage complex projects across development and commercialization stages while developing new CMC leads through mentorship. Establish partnerships with key customers and counterpart functions to facilitate effective collaboration.

Required Qualifications

  • Bachelor's Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development)
  • Master's Degree with 14+ years of relevant experience
  • PhD Degree with at least 12+ years of relevant experience
  • CMC development experience through IND and/or NDA/MAA
  • Technical understanding and experience with small molecule products manufacturing, development, quality and analytics
  • Knowledge and experience with FDA and global regulatory requirements for CMC issues

Desired Qualifications

  • Experience leading multiple CMC project teams through IND and NDA/MAA preferred

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