Contract Project Manager
- CMC Project Management (70%)
- Serve as CMC project manager and assist the CMC lead in executing non-GMP and GMP manufacturing campaigns.
- Coordinate regular team meeting schedules, draft agendas, and provide meeting minutes, action items, and progress reports according to project management best practices.
- Collaborate cross functionally to monitor CMC activities and ensure alignment with CMC goals and timeline.
- Maintain documentation of CMC projects in program Sharepoint.
- Develop and maintain visual project tools including dashboards, metrics reports and Gantt charts to provide leadership and teams with clear, up-to-date view of study status, risks, and progress.
- Track and maintain data in Smartsheet/sharepoint: update actions, decisions, and risks in program registers, identify risks or potential bottlenecks in CMC projects, and escalate issues.
- Support CMC in regulatory activities by facilitating alignment in regulatory documents generation (i.e., IND module 3)
- Provide regular status reports to leadership and project team members.
- Program Management (30%)
- In collaboration with PM lead, develop, and maintain integrated program timelines across different teams.
- Provide PM support in clinical development initiatives (i.e., start up activities, regulatory operations activities).
- Demonstrate critical thinking to improve PM practices
- Bachelor's degree in biology, biotechnology, project management or related field (PMP certification preferred)
- 2+ years of experience in CMC project management required
- Experience managing projects in biotech, pharmaceutical, or related R&D environments, with exposure to CMC and clinical development.
- Familiarity with the drug development lifecycle—from preclinical activities through IND-enabling studies—and demonstrated ability to coordinate across teams.
- Advanced proficiency with project management tools such as Smartsheet, including the ability to build and maintain project registers, trackers, and Gantt charts.
- Experience coordinating across cross-organizational teams (internal scientists, external CROs, regulatory/quality, operations).
- Prior experience managing complex projects and ability to drive consensus across multiple teams.
- Commitment to our Core Values: Respect, Integrity, Excellence, Impact
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