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CMC Project Manager

Company: NextPoint Therapeutics, Inc.
Location: Cambridge
Posted on: November 22, 2022

Job Description:

SummaryProject Manager (PM) with an Operations focus, in partnership with the project's Technical Lead and other internal and external team members, working with team for successful coordination of process development and manufacturing activities.
Responsibilities:

  • Identification of opportunities to accelerate submissions and performing scenario planning
  • Develop integrated CMC project plans for assigned project(s) with the CMC Project Lead and the CMC team
  • Ensure project plan alignment with portfolio priorities and capacity
  • Define the project budget and track spending
  • Analyze, monitor, and report on CMC project plan execution
  • Contribute to project documents and governance meetings preparation
  • Promote and ensure implementation of Good Project Management practices
  • Enable the Project Team's scenario planning through analyses of downstream impact and visualization of scenarios
  • Assess the Team's needs and gaps and provide targeted project management solutions.
  • Drive lessons learned sessions and supply secure environment to evaluate project related activities and learn from earlier experience.
  • Drive activities to be completed on time. Any substantial acceleration or delay on the project is communicated promptly to project leadership and corporate management, and corrective actions are put in place as needed
  • Track activities to ensure that project execution is consistent with the integrated development plan, to budget, resourcing, scope, and timelines.
  • Report progress to relevant stakeholders
  • At project level, partner with internal and external stakeholders (teams, functions, governance, alliance partners, licensees, vendors as needed) to set up a safe, collaborative environment for effective project communications and to manage change by motivating towards common goals while championing conflict resolution and accountability.
  • Ensure alignment within the development team and across the company
  • Ensure decisions are documented and communicated appropriately. This may involve external partners
    Experience and Qualifications:
    • B.S. or M.S. in biology, molecular biology, biochemistry, bioengineering, immunology, or related field
    • At least 3 years of Program Management experience in a Pharmaceutical or Biotech environment
    • A high level of initiative, good judgment, and the ability to work with little supervision.
    • Strong interpersonal skills; effective and proactive communication and ability to collaborate with a wide array of personalities and work styles, and across functional areas
    • Great attention to detail, including a proven ability to manage multiple, competing priorities simultaneously, as well as the ability to think strategically and execute methodically
    • Knowledge in CMC process development and manufacturing for biologics
    • Able to support project leadership and function Leads during the budget process and manage overall project budget oversight

Keywords: NextPoint Therapeutics, Inc., Cambridge , CMC Project Manager, Executive , Cambridge, Massachusetts

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