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Senior Project Manager, CMC

Company: Germer International
Location: Rockville
Posted on: June 15, 2022

Job Description:

Summary of Position
The Sr. Project Manager for CMC leads several programs in our client's pipeline and is responsible for cross-functional CMC strategy and operational matrix management of the CMC development plan, which includes activities in biopharmaceutical process development, manufacturing, quality and regulatory affairs. The Sr. Project Manager for CMC also leads the alliance management for CMC contract and with collaboration partners to ensure completion of deliverables.
Responsibilities and Job Duties:

  • Leads the cross-functional CMC team meetings and ensure team focus on key decisions and milestones and drive accountability to achieve goals
  • Champions the CMC aspects (strategic and operational) to the Product Development Teams (PDT) for assigned product development programs.
  • Leads the development of and maintains the integrated CMC plan (activities and timelines).Ensures proper alignment with the overall project plan.
  • Monitors deliverables and communicates regular updates of program status to stakeholders via dashboards and other cross-portfolio project management tools
  • Independently manages day to day project and/or team activities and issues; obtains management guidance for strategic or complex topics
  • Collaborates with functional representatives to proactively anticipate and identify project risks and develop action and resolution plans
  • Ensures the team and stakeholders have the right information for decisions and leads the team through problem solving, decision discussions and contingency planning
  • Establishes and maintains effective communication channels to provide accurate information to the CMC Management Team, functional line management, PDT and other governance bodies (internal and external) as required.
  • Chairs joint meetings with partners including proactive agenda development and meeting preparation
  • Acts as liaison between internal and partner project teams and drive collaborative planning and execution to achieve partnership goals and objectives.
  • Assists in maintaining CMC project management tools like cross-functional program portfolio timelines, publishing monthly CMC dashboards, building CMC goals, etc.

    Minimum Qualifications
    Education & Credentials

    • Bachelor's degree in a relevant technical or scientific discipline

      Sr. Project Manager

      • At least 7 years' experience in biotech/pharma industry with relevant Bachelor's degree


        • At least 5 years' experience with Master's degree in a scientific field
        • A minimum of 3 years of prior experience managing CMC projects
        • Direct experience in one or more areas of CMC biopharmaceutical or related product development field (e.g. process development, technical services, quality, manufacturing, regulatory, clinical supply)

          Knowledge, Skills and Abilities

          • Demonstrated understanding of project management principles applicable to bio/pharma
          • Demonstrated ability to balance scientific, technical and business priorities
          • Capable of concurrently and efficiently managing multiple projects
          • Well-organized with ability to effectively prioritize
          • Ability to navigate project teams throughout ambiguous situations
          • Conflict management skills
          • Strong decision-making skills
          • Demonstrated ability to work with cross-functional teams in a matrix environment
          • Strong interpersonal skills, collaborative mindset, ability to develop working relationships with colleagues at all levels of the organization
          • Strong written and verbal communication skills are required
          • Planning and monitoring skills with strong attention to detail including direct experience with project management tools

            Preferred Qualifications

            • Professional project management certification
            • Experience managing or leading teams
            • Experience in managing external partners (collaborators)
            • Experience in the generation of regulatory filings (INDs and BLAs)

Keywords: Germer International, Rockville , Senior Project Manager, CMC, Executive , Rockville, Maryland

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