3h ago

Associate Director, CMC Project Management

Cambridge, MA

$165,000-$205,000 / year

full-timedirectorbiotechnology

Tech Stack

Description

You will develop and deliver CMC project plans, define critical paths, and support risk management to enable the delivery of a complex, innovative CMC portfolio. You will collaborate with CMC team leads and functional leaders to improve execution and replicate successes across programs, helping bring new medicines to patients.

Requirements

  • Bachelor's degree in relevant science or engineering field
  • 6+ years in pharma/life sciences, including 4+ years CMC development or CMC project management
  • Experience taking programs to IND and pivotal IND submission
  • Expert knowledge of project management methodologies, concepts, and tools
  • Track record in matrix organization and influencing across multi-site, multi-function teams

Responsibilities

  • Develop master project plan using MS Project or Smartsheet, define critical path and monitoring mechanisms
  • Publish regular dashboards to align team on project progress and critical path modifications
  • Support CMC team on enabling decisions and risk management
  • Create and maintain cross-functional CMC project plan, keep team activities and timelines on track
  • Identify potential CMC risks, resource constraints, and conflicts; work with team to develop mitigation strategies
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