Associate Director, Program Management - CMC

Job Locations US-MA-Bedford
Posted Date 1 month ago(6/18/2021 12:18 PM)
Job ID
# of Openings
General & Adminstrative


The Associate Director, CMC Program Management will be responsible for managing the CMC activities for development programs in the pre-clinical to launch space for both internal and partnered programs.


  • Lead cross-functional CMC teams to develop and execute the CMC strategy for assigned programs; ensure agendas and minutes, action items and decisions are documented
  • Collaborate with team members to create and maintain integrated CMC Gantts to drive on-time release of supplies for multiple matrixed, complex programs
  • Define and document integrated CMC program plan to include the schedule, budget, and resource allocation in accordance with the strategic goals and priorities of the organization
  • Monitor the scope of the programs and projects to identify and report on potential changes that may have an impact to quality, time or cost.
  • Proactively manage CMC program risks and mitigation plans; follow a communication plan to escalate when necessary
  • Attend core team meetings to ensure alignment across all functions with development activities
  • Prepare status updates and dashboards for technical review forums and communication to senior leadership
  • Develop and deliver engaging, informative and well-organized presentations that provide regular updates and recommendations on the program status, including milestones achieved, mitigation plans for identified delays or risks, and changes in scope and financials
  • Participate in the development of program management best practices for the team, including creation of templates and business process improvements
  • Assume additional responsibilities as assigned


  • Minimum 5 years of Project Management experience
  • 10+ years of experience in the Biotechnology or Life Science industry
  • Technical degree in Engineering or science fields preferred; advanced degree in science or business is preferred
  • Experience working in CMC or with CMC teams
  • Ability to work in a fluid environment and foster a strong collaborative spirit
  • Ability to negotiate and sustain networking relationships
  • Solid judgement with ability to make good decisions
  • Excellent written and oral communication skills
  • Excellent time management and organizational skills
  • Strong knowledge of project management tools/software (Microsoft Project or Smartsheet), and digital solutions


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