CMC Project Manager

Akebia Therapeutics, Inc   •  

Cambridge, MA

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 58 days ago

This job is no longer available.

Job Description

Akebia is looking for someone with energy, creativity, and vision to grow with us as we build our portfolio and program governance processes. The CMC Project Manager will help set the structure and lead execution of projects in support of the Akebia strategic objectives. In this position, you will have the opportunity to have a direct impact on the success of Akebia in treating patients with chronic kidney disease

Required Skills

  • Mobilize cross-functional project teams with members from Manufacturing, Quality, Planning and Regulatory to support CMC strategy.
  • Leverage input from all critical functions to create integrated project plans that define goals, milestones, critical path, timeline, risks, assumptions, and alternative scenarios.
  • Lead and manage all aspects of the CMC portfolio, including conducting program and project team meetings, managing team activities via agendas and minutes, and managing competing objective and resources.
  • Create strong relationships with team members and functional line managers. Serve as key point person for Operations team members for project status communications, issue identification, and scope change management.
  • Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipates risks, creates contingency plans and decision-making exercises in collaboration with project teams. update project timelines, communicate progress, and maintain the CMC program dashboard.
  • Informs key stakeholders of status, issues, problems, and proposed solutions. Effectively communicate with CMC senior management on program strategy, operational plans and progress
  • Foster a positive team culture of ownership and accountability including continuous evaluation, recognition, and process improvement.

Required Experience

Basic Qualifications:

  • Bachelor's degree
  • 8+ years' experience in biopharmaceutical industry
  • Experience managing cross-functional teams

Preferred Qualifications:

  • Strong understanding of all aspects of biopharmaceutical drug development, including clinical, nonclinical, regulatory, CMC and commercial
  • Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization
  • Experience in the application of traditional program management principles and practices
  • Excellent oral and written communication skills, including presentation and facilitation skills
  • Strong analytical and problem solving skills, including an ability to combine attention to detail with a big picture perspective
  • Ability to work independently and with flexibility to handle work flow in a fast-paced environment
  • Knowledge of project management processes and tools including Smartsheets or MS project