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Latitude, Inc. CMC Project Manager in Gaithersburg, Maryland

The CMC Project Manager will work with the CMC group and manage activities at multiple CMOs and analytical contract laboratories to ensure product development project goals and milestones are achieved. The successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.

Responsibilities:

  • The Project Manager is responsible for providing project management (PM) support for the CMC Commercialization framework continuous improvement efforts.

  • Coordinating ongoing improvements to the CMC framework primarily based on already established and development in progress business processes

  • Assist with tracking and collaborating with stakeholders to successfully fulfill critical milestones

  • Schedule cross-functional and cross-site CMC alignment meetings with key stakeholder

  • Project management of multiple project work-streams

  • Assist with the development and management of PM materials for work-stream

  • Collaborate with key stakeholders to successfully align and incorporate business processes into the existing CMC framework

  • Assist with the maintenance and updating of user manuals, roadmaps, and training materials

  • Ensure project work complies with established practices, policies, and processes

  • Support other department projects where necessary

  • Contribute to department initiatives

Requirements:

  • 3+ years of relevant experience and a BA or BS or; 4+ years of relevant experience and a MS or MBA

  • Possess a strong working knowledge of drug development and manufacturing processes in a health authority regulated environment

  • Relevant experience consisting of experience with pharmaceutical CMC activitiesand/or cross-functional project management preferred

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