AD CMC PM

Precision Life Sciences - Waltham, MA

AD CMC PM

The Role:

  • Develop and maintain fully integrated CMC project plans, incorporating activities, internal/external resource requirements and key interdependencies, that deliver tangible results against program and corporate goals.
  • Establish and implement operational mechanisms to facilitate effective and timely cross-functional communication and decision making, and successful execution of program plans.
  • Provide team and meeting management, including taking minutes and ensure follow-up on action items
  • Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across functions and programs
  • Identify, define, prioritize, and communicate risks to successful program execution; develop and monitor risk mitigation and contingency plans.
  • Manage and coordinate multiple projects to ensure they are completed on time and on budget
  • Organize and plan project tasks and schedules utilizing, Smartsheets, MS-Project or any other tools provided
  • Manage tasks in accordance with Project Management Institute (PMI) standards and those of the company
  • Communicate project status to stakeholders and key project participants
  • Stay aware of CMC goals and strategies to ensure projects align with business priorities
  • Facilitate and encourage collaboration across departments to ensure projects are completed successfully
  • Manage and facilitate the CMC meetings, activities include, meeting minutes, agenda, setting up critical meetings as needed and action items
  • Sit on the sub-team meetings as needed, support the leadership team, and align strategy with key stake holders
  • Create presentations, dashboards, and reports to communicate project status, key internal metrics, or risk mitigations
  • Keep the project team focused on the end goal

Qualifications

  • A minimum of 7 years of R&D and/or drug development project management or cross-functional team leadership experience in the pharmaceutical industry; with a preference for project management certification by a recognized project management organization (e.g. PMI, IPMA)
  • Direct experience in manufacturing, operations and/or CDMO management
  • Proven success working in cross-functional teams
  • Strong scientific background and knowledge of the Drug Development Process
  • Skill in fostering open communication, mutual understanding, and cooperation
  • Strong understanding of Microsoft Project, Power Point and Excel along with Smartsheet and/or any other project related software.
  • Experience in managing multiple programs at one time, can work well with different management styles to keep a project moving.
  • Track record of success in managing cross-functional meetings and supporting team leads.
  • Competency in developing, implementing, and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
  • Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a cross- functional team environment.
  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is preferred
  • A degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired


Posted On: Monday, November 28, 2022



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