AVI Project Manager

Purpose: We are looking for a Project Manager to join our team that always seeks what is best for our patients and customers, challenges common thinking to get a better result, is an effective problem solver, and is a team player that helps others. Diversification continues to bring new products/projects to the Waterford site and the expanded site portfolio continues to create new opportunities. The role of contract Project Manager will lead cross- functional teams in the introduction and business integration of the following projects: Responsibilities:

Project Manager for the following:

• mAbs and LYO Automated Visual Inspection PPQs and Regulatory Submission
• Project Manager responsibilities to support the above projects will include:
• Lead cross-functional, multi-site teams, in the introduction and business integration of projects.
• Translate customer needs into defined, approved project scope statements
• Work with functional managers to quantify resource requirements.
• Establish detailed project plans and drive execution of project tasks in line with agree scope, schedule, and cost.
• Run regular project meetings to lead and influence the project, adhere to scope, and ensure timely completion according to schedule.
• Establish and execute a communication plan for the project and facilitate information flow between stakeholders and sites.
• Drive project risk identification, analysis, response, and implement & monitor mitigations to minimise impact to the project or wider business.
• Facilitate cost estimation to determine project budget and drive adherence to budget and forecast submission
• Project Stakeholder Management to analyze stakeholder expectations and their impact on the project, and to develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution.
• The project manager is responsible for some project GMP documents in line with Waterford site procedures; therefore, training to Waterford GMP systems is required.

Requirements

• Experience in biopharma industry, in a project leadership role
• Degree in Science, Engineering or equivalent
• Demonstrated experience in project/program management in drug substance or drug product
• Project Management certification, PMI, etc
• Working knowledge of cGMP's, GLP etc