Purpose

This position provides leadership and project management for new product introduction (NPI) projects and routinely manufactured products. The Project Manager will work independently with business partners to lead projects including communications, project planning, risk/issue management, stakeholder management, scheduling, team meetings, and internal and external client engagement.

Responsibilities

• Assemble and lead matrixed cross-functional teams comprised of scientists and engineers responsible for all operational aspects of drug substance process development, characterization, manufacture, quality assurance and quality control.
• May manage new product launches to ensure all filling and launch targets are met.
• Gather required project plan inputs then develop, maintain and execute the cross-functional project plan. Track and hold team accountable for measurable actions.
• Maintain compliance with regulatory agencies, functional systems, ethics policies and project goals.
• Identify and anticipate schedule changes and their impact to scope and deliverables.
• Present project status to management and stakeholders at scheduled management update meetings and client steering meetings.
• Develops team charter, implementation plans, conducts risk assessments and develops and implements contingency plans to accommodate unforeseen events and changes in strategy.
• May be responsible for indirect and/or direct management of contract coordinator and/or associated project management staff including workload management, quality deliverables, and escalation of issues to management when needed.