Senior Manager / Associate Director, CMC Project Management
New
P
PulmovantBiotechnology
Remote (US-based), with periodic travelFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- Senior Manager: 5+ years of relevant professional experience, including 2+ years in a project or program management capacity. Associate Director: 8+ years, including 4+ years in a project or program management capacity.
- Required Skills
- Project ManagementSharePointMicrosoft ExcelPowerPoint
Requirements
- Bachelor’s degree in a scientific, engineering or other technical discipline, or equivalent practical experience.
- Senior Manager candidates: 5+ years of relevant professional experience, including 2+ years in project or program management.
- Associate Director candidates: 8+ years of relevant professional experience, including 4+ years in project or program management.
- Demonstrated project management track record; biopharmaceutical CMC experience is strongly preferred.
- Familiarity with drug substance and drug product development, analytical development, GMP manufacturing and CDMO/CMO work, or a credible plan to develop that familiarity quickly.
- Experience building and maintaining integrated timelines in Smartsheet, Microsoft Project, Office Timeline, Planisware or an equivalent planning tool.
- Experience driving cross-functional teams to deliver against project timelines.
- Strong working proficiency with Excel, PowerPoint and SharePoint/Teams, and fluency or fast aptitude with timeline and dashboard tools.
- Experience supporting programs through clinical development (Phase 1–3) is valued; late-stage or registrational experience is a plus.
- PMP, PgMP or equivalent certification is a plus but not required.
Responsibilities
- Build, maintain and communicate integrated CMC timelines aligned with clinical development and regulatory milestones.
- Run CMC team meetings, including agendas, minutes, decisions and action-item tracking through closure.
- Maintain the program’s source of truth for deliverables, owners and due dates.
- Track risks, issues, assumptions and dependencies across CMC and cross-functional workstreams, escalating and driving resolution or mitigation.
- Partner with CMC technical leads to translate technical strategy into executable project plans.
- Coordinate CDMO/CMO deliverables, meeting cadence and document tracking with technical and quality leads.
- Maintain CMC budget and spend trackers and support purchase order, invoice and accrual reconciliation.
- Track CMC regulatory submission authoring, review and approval milestones with Regulatory Affairs.
- Develop and maintain timelines, dashboards and status reports for internal stakeholders and leadership.
- Prepare materials for governance and leadership reviews, including program updates and key decision points.
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