Project Manager-Manufacturing Transfer

Job Title: Project Manager

Company: Intellectt Inc

Location: Arvada, CO

Employment Type: Contract

Job Summary

We are seeking an experienced Senior Program Manager – Manufacturing Transfer to lead and coordinate complex manufacturing and plant transfer initiatives within the medical device industry. The ideal candidate will have extensive experience managing cross-functional programs, transferring manufacturing operations between sites, and coordinating with Contract Manufacturing Organizations (CMOs) to ensure successful product and process transfers.

This role will oversee project governance, integrated planning, manufacturing and process validation, regulatory compliance, supply chain readiness, risk management, and financial tracking. The successful candidate will work closely with internal teams, external manufacturing partners, quality and regulatory functions, engineering, and senior leadership to ensure transfers are completed on schedule while maintaining product quality and continuity of supply.

Key Responsibilities

1. Project Leadership and Governance

• Maintain a single source of truth for project plans, including schedules, budgets, milestones, tasks, dependencies, and deliverables.
• Develop and manage integrated project plans, critical path activities, and milestone schedules.
• Execute the plant transfer strategy and roadmap in alignment with the Contract Manufacturer (CM) plan.
• Support the Project Head in establishing governance structures, steering committees, and cross-functional workstreams.
• Drive decision-making and issue resolution across multiple stakeholders.
• Provide direction to project team members, remove barriers to progress, and resolve resource constraints.
• Support regular program status updates, risk reviews, and executive reporting.
• Facilitate cross-functional core team meetings to review progress, resolve issues, and align on program objectives.
• Coordinate preparation of materials for STC, PRC, and other governance meetings.
• Maintain program-level KPI dashboards to identify risks early and drive continuous improvement.

2. Manufacturing and Plant Transfer Management

• Lead and coordinate manufacturing transfer activities between sites and external manufacturing partners.
• Coordinate the transfer of manufacturing processes, technical documentation, equipment requirements, and operational knowledge.
• Ensure continuity of supply throughout the transition and stabilization phases.
• Monitor transfer readiness, production capacity, resource availability, and operational performance.
• Coordinate pilot builds, engineering builds, and production qualification runs with contract manufacturers.

3. Product and Process Transfer

• Ensure the complete and controlled transfer of:
• Bills of Materials (BOMs)
• Manufacturing instructions and work instructions
• Process specifications and equipment parameters
• Test methods and inspection procedures
• Validation protocols and reports
• Product history and manufacturing records
• Coordinate engineering and production readiness activities.
• Ensure transfer deliverables are complete, documented, reviewed, and approved by the appropriate functions.

Pay Scale

Anticipated hourly pay range: $40/hr to $45/hr.