Senior Project Manager, External Manufacturing
Core
Manage a portfolio of molecule-specific programs for External Manufacturing Drug Product, ensuring execution according to life cycle management strategy.
Role type
Senior Project Manager (External Manufacturing)
Builds
External Manufacturing projects (Technical Transfers, Process Validation, new CMO selection, CapEx, Life Cycle Management)
Domain
Pharmaceutical manufacturing
Required skills
Project management, cross-functional team leadership, CMO/CRO collaboration, risk mitigation, budget forecasting, stakeholder alignment, regulatory knowledge (GxP, ISO, ICH), project management software proficiency
Preferred skills
PMP certification, MBA, experience managing direct reports, advanced MS Project/Excel skills
Responsibilities
Lead cross-functional teams to execute development strategy; Act as single point of contact for CMOs and CMC Program Manager; Drive adherence to project timelines and risk mitigation; Plan, track, and deliver project activities; Ensure stakeholder alignment on project execution plans; Organize project meetings with CMOs; Facilitate contingency and risk mitigation planning; Oversee integrated project budgets and KPIs; Manage a team of Project Managers for clinical technical transfers and PPQs.
Seniority
Senior, hands-on IC with direct reports