New Products Introduction Project Manager

The New Products Introduction Project Manager is responsible for planning, coordinating, and executing technology transfer and product variation projects within the pharmaceutical manufacturing environment.

This role ensures successful delivery of project objectives, including timelines, budgets, and regulatory compliance, while facilitating collaboration between clients and internal departments.

• Develop the Technology Transfer Plan and/or Change Control documentation, including project budgets, timelines, and team structures.
• Draft and circulate plans for review, feedback, and approval.
• Create and maintain a comprehensive project schedule with activities, responsibilities, and deadlines.
• Manage project execution to meet established goals for deliverables, timelines, and budgets.
• Identify project stakeholders and ensure effective communication of client requirements to the manufacturing plant.
• Schedule and coordinate necessary meetings, teleconferences, and updates.
• Act as a liaison between departments and clients, fostering collaboration and resolving issues.
• Coordinate and contribute to the preparation of key documents, including:
  • Change Controls (CC)
  • User Requirement Specifications (URS)
  • Quality Agreements (QA)
  • Analytical Transfer Protocols (AMT)
  • Risk Analyses
  • Process and Cleaning Validation Protocols (PVP)
  • Stability Plans, Specifications, and Artworks
• Ensure all project documentation meets regulatory and company standards.
• Track project progress, identify potential risks, and implement solutions to mitigate delays or issues.
• Support investigations and problem-solving throughout the project.
• Manage project budgets and expenses, providing updates as needed.
• Finalize all required documentation and reports for project completion (e.g., TTP Report).
• Communicate the completion of billable activities to relevant stakeholders.
• Provide support and expertise for other projects when needed.

Permanent

From 3 to 5 years